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Deb C
Hi?Happy New Year to All...and more appropriate...Happy Almost Valentine's Day! As many of you may know, it was an eventful 2005-2006 for us. John continues to work on his therapy after another valve replacement surgery and multiple strokes about this time last year. We are very thankful to have made it through another year. John is still recovering?and this is where we are asking for any help or assistance you could offer.
We are trying to locate people and/or families and professionals who have experience and/or knowledge with CryoLife allograft heart valves and SynerGraft decellularized homograft heart valves. If you would be willing to share your story or information and/or resources, please respond to this posting.
Thank you. Deb Cochran, loving wife of John. And please know that although you don't hear from us as often as before, we think of all of you with warmth (we are in MN!) and love! Your courage and support have been inspiring!
PS?
We have been trying to get information from the FDA and several other government agencies since our formal Freedom of Information request in February 2006 concerning CryoLife Inc. and the human SynerGraft and allograft valves they have provided to the public. It is been nearly a year, and we have received very little information. Evidently, if enough people request the information, they will post it on the FDA Web site.
If you would be willing to forward a request the government under the Freedom of Information Act, please copy the following letter request and send it to these agencies:
Food and Drug Administration (FDA) *
Freedom of Information Officer
Parklawn Building, Room 6-30
5600 Fishers Lane
Rockville, Maryland 20857
Phone: 301-827-6567
FOIA Officer: Betty Dorsey
FOIA Public Liaison: Betty Dorsey
Health Resources and Services Administration (HRSA) *
Freedom of Information Officer
Parklawn Building, Room 14-15
5600 Fishers Lane
Rockville, Maryland 20857
Phone: 301-443-3376
FOIA Officer: Mona Finch
FOIA Public Liaison: Mona Finch
Dear Madam:
Please consider this letter a request for documents and/or information pursuant to the Freedom of Information Act, 5 U.S.C. § 552.
We understand that the FDA issued an order in August 2002 to CryoLife, Inc. (Kennesaw, GA) to withhold from the market and recall all of its human allograft tissues distributed since October 31, 2001, in light of various regulatory violations and contamination issues discovered by the FDA and/or the CDC. While the FDA?s order exempted Cryo-preserved allograft heart valves, we understand that the FDA and/or CDC nonetheless have serious concerns regarding the processing and handling of CryoLife?s heart valves. We also understand the FDA and/or CDC considers CryoLife?s human allograft heart valves, as well as its SynerGraft decellularized homograft heart valves, to be ?medical devices.?
This office is requesting all documents and/or information the FDA and/or CDC may have regarding CryoLife allograft heart valves and SynerGraft decellularized homograft heart valves. Among other information and/or documents the FDA and/or CDC may have regarding these valves, please send to us the following:
? All documents and/or information FDA and/or CDC have showing their determination, finding, conclusion, or belief that CryoLife allograft heart valves and/or SynerGraft decellularized homograft heart valves are ?medical devices? falling within FDA and/or CDC rules and/or regulations;
? All documents and/or information FDA and/or CDC have showing any human injury or product defects relative to CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding any instruction or warning by the FDA and/or CDC to CryoLife preventing or restricting the utilization of any Cryo-preserved allograft heart valve and/or SynerGraft decellularized homograft heart valves in a human;
? All documents and/or information FDA and/or CDC have as to structural deterioration subsequent to implantation of CryoLife allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding fungal or bacterial contaminations or infections relating to CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding CryoLife?s violations of any regulatory violation relating to the processing of human tissues and/or CryoLife?s failures to implement corrective actions, including but not limited to CryoLife?s violations of 21 C.F.R. 1270 et seq.
? All documents and/or information FDA and/or CDC have regarding CryoLife?s procedures and/or protocols for processing, handling, and/or testing with respect to its allograft heart valves and/or SynerGraft decellularized homograft heart valves, as well as any documents and/or information regarding CryoLife?s compliance with such procedures and/or protocols;
? All documents and/or information FDA and/or CDC have regarding CryoLife?s distribution of tissue from donors after confirmation that such donors had harmful microorganisms, infections, or contaminants;
? All documents and/or information FDA and/or CDC have regarding the FDA?s discovery, in March 2002, of a patient with a CryoLife allograft heart valve who developed a fever within two months of surgery;
? All documents and/or information FDA and/or CDC have regarding cultures of the CryoLife allograft heart valve and/or SynerGraft decellularized homograft heart valve growing Candida Tropicalis, Candida Albicans, or any other infections;
? All documents and/or information FDA and/or CDC have regarding FDA?s discovery, in March 2002, of a patient who had received a CryoLife allograft heart valve and subsequently tested positive for Staphylococcus Epidermidis;
? All documents and/or information FDA and/or CDC have regarding FDA?s and/or CDC?s inspections of CryoLife?s facilities, including the December 3, 2001 ? December 7, 2001 inspections and March 25, 2002 ? April 12, 2002 inspections of CryoLife?s facilities, including but not limited to findings, reports, and warnings, such as the May 15, 2002 CryoLife Letter to FDA, the June 17, 2002 Warning Letter to CryoLife, the June 25, 2002 CryoLife Letter to FDA, and any other related correspondence, tests, reports, or other related documents;
? All documents and/or information FDA and/or CDC have regarding reports or complaints of defects, contamination, infections, or complications from the use of CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding CryoLife?s marketing and selling of its allograft heart valves and/or SynerGraft decellularized homograft heart valves, including representations regarding the safety and efficacy of the valves;
? All documents and/or information FDA and/or CDC have regarding the safety and/or effectiveness of CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves, including any studies, tests, reports, warranties, data, or the results of tests;
? All documents and/or information FDA and/or CDC have regarding past, pending, or existing litigation, civil or criminal, regarding the CryoLife, Inc. heart valve and/or SynerGraft decellularized homograft heart valve.
In the event any of the information requested is available on your websites, and in lieu of copying and sending us such information, please specify which information is available online by providing us a link to that information. Otherwise, please provide responsive documents and/or information to the following:
Roger R. Roe, Jr.
Best & Flanagan LLP
225 South Sixth Street, Suite 4000
Minneapolis, MN 55402
(612) 339-7121
Finally, please notify us in advance in the event the costs of this request exceed $250.00, and do not hesitate to contact Roger with any questions or concerns. Thank you for your courtesy.
Very truly yours,
We are trying to locate people and/or families and professionals who have experience and/or knowledge with CryoLife allograft heart valves and SynerGraft decellularized homograft heart valves. If you would be willing to share your story or information and/or resources, please respond to this posting.
Thank you. Deb Cochran, loving wife of John. And please know that although you don't hear from us as often as before, we think of all of you with warmth (we are in MN!) and love! Your courage and support have been inspiring!
PS?
We have been trying to get information from the FDA and several other government agencies since our formal Freedom of Information request in February 2006 concerning CryoLife Inc. and the human SynerGraft and allograft valves they have provided to the public. It is been nearly a year, and we have received very little information. Evidently, if enough people request the information, they will post it on the FDA Web site.
If you would be willing to forward a request the government under the Freedom of Information Act, please copy the following letter request and send it to these agencies:
Food and Drug Administration (FDA) *
Freedom of Information Officer
Parklawn Building, Room 6-30
5600 Fishers Lane
Rockville, Maryland 20857
Phone: 301-827-6567
FOIA Officer: Betty Dorsey
FOIA Public Liaison: Betty Dorsey
Health Resources and Services Administration (HRSA) *
Freedom of Information Officer
Parklawn Building, Room 14-15
5600 Fishers Lane
Rockville, Maryland 20857
Phone: 301-443-3376
FOIA Officer: Mona Finch
FOIA Public Liaison: Mona Finch
Dear Madam:
Please consider this letter a request for documents and/or information pursuant to the Freedom of Information Act, 5 U.S.C. § 552.
We understand that the FDA issued an order in August 2002 to CryoLife, Inc. (Kennesaw, GA) to withhold from the market and recall all of its human allograft tissues distributed since October 31, 2001, in light of various regulatory violations and contamination issues discovered by the FDA and/or the CDC. While the FDA?s order exempted Cryo-preserved allograft heart valves, we understand that the FDA and/or CDC nonetheless have serious concerns regarding the processing and handling of CryoLife?s heart valves. We also understand the FDA and/or CDC considers CryoLife?s human allograft heart valves, as well as its SynerGraft decellularized homograft heart valves, to be ?medical devices.?
This office is requesting all documents and/or information the FDA and/or CDC may have regarding CryoLife allograft heart valves and SynerGraft decellularized homograft heart valves. Among other information and/or documents the FDA and/or CDC may have regarding these valves, please send to us the following:
? All documents and/or information FDA and/or CDC have showing their determination, finding, conclusion, or belief that CryoLife allograft heart valves and/or SynerGraft decellularized homograft heart valves are ?medical devices? falling within FDA and/or CDC rules and/or regulations;
? All documents and/or information FDA and/or CDC have showing any human injury or product defects relative to CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding any instruction or warning by the FDA and/or CDC to CryoLife preventing or restricting the utilization of any Cryo-preserved allograft heart valve and/or SynerGraft decellularized homograft heart valves in a human;
? All documents and/or information FDA and/or CDC have as to structural deterioration subsequent to implantation of CryoLife allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding fungal or bacterial contaminations or infections relating to CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding CryoLife?s violations of any regulatory violation relating to the processing of human tissues and/or CryoLife?s failures to implement corrective actions, including but not limited to CryoLife?s violations of 21 C.F.R. 1270 et seq.
? All documents and/or information FDA and/or CDC have regarding CryoLife?s procedures and/or protocols for processing, handling, and/or testing with respect to its allograft heart valves and/or SynerGraft decellularized homograft heart valves, as well as any documents and/or information regarding CryoLife?s compliance with such procedures and/or protocols;
? All documents and/or information FDA and/or CDC have regarding CryoLife?s distribution of tissue from donors after confirmation that such donors had harmful microorganisms, infections, or contaminants;
? All documents and/or information FDA and/or CDC have regarding the FDA?s discovery, in March 2002, of a patient with a CryoLife allograft heart valve who developed a fever within two months of surgery;
? All documents and/or information FDA and/or CDC have regarding cultures of the CryoLife allograft heart valve and/or SynerGraft decellularized homograft heart valve growing Candida Tropicalis, Candida Albicans, or any other infections;
? All documents and/or information FDA and/or CDC have regarding FDA?s discovery, in March 2002, of a patient who had received a CryoLife allograft heart valve and subsequently tested positive for Staphylococcus Epidermidis;
? All documents and/or information FDA and/or CDC have regarding FDA?s and/or CDC?s inspections of CryoLife?s facilities, including the December 3, 2001 ? December 7, 2001 inspections and March 25, 2002 ? April 12, 2002 inspections of CryoLife?s facilities, including but not limited to findings, reports, and warnings, such as the May 15, 2002 CryoLife Letter to FDA, the June 17, 2002 Warning Letter to CryoLife, the June 25, 2002 CryoLife Letter to FDA, and any other related correspondence, tests, reports, or other related documents;
? All documents and/or information FDA and/or CDC have regarding reports or complaints of defects, contamination, infections, or complications from the use of CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves;
? All documents and/or information FDA and/or CDC have regarding CryoLife?s marketing and selling of its allograft heart valves and/or SynerGraft decellularized homograft heart valves, including representations regarding the safety and efficacy of the valves;
? All documents and/or information FDA and/or CDC have regarding the safety and/or effectiveness of CryoLife?s allograft heart valves and/or SynerGraft decellularized homograft heart valves, including any studies, tests, reports, warranties, data, or the results of tests;
? All documents and/or information FDA and/or CDC have regarding past, pending, or existing litigation, civil or criminal, regarding the CryoLife, Inc. heart valve and/or SynerGraft decellularized homograft heart valve.
In the event any of the information requested is available on your websites, and in lieu of copying and sending us such information, please specify which information is available online by providing us a link to that information. Otherwise, please provide responsive documents and/or information to the following:
Roger R. Roe, Jr.
Best & Flanagan LLP
225 South Sixth Street, Suite 4000
Minneapolis, MN 55402
(612) 339-7121
Finally, please notify us in advance in the event the costs of this request exceed $250.00, and do not hesitate to contact Roger with any questions or concerns. Thank you for your courtesy.
Very truly yours,
