TAVR/TAVI: Recall of SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery

[Seaton]

https://www.fda.gov/medical-devices...very-system-due-burst-balloons-during-surgery

 

[pellicle]

oops

 

[user 16827]

very unfortunate for the 1

it is never an easy decision to make, i struggled with it

 

[dwhist]

I read the article the other day. It is called a recall, but is not a recall. I believe it is information sent to the surgeons letting them know when using the system they need to inflate the balloon slowly. Because of the change in delivery, they had to call it a recall.

 

[rich01]

So 1 week after FDA approves the valve for low risk patients, they recall the delivery system?

Doesn't inspire a lot of confidence in FDA approval process.

 

[Seaton]

I read the article the other day. It is called a recall, but is not a recall. I believe it is information sent to the surgeons letting them know when using the system they need to inflate the balloon slowly. Because of the change in delivery, they had to call it a recall.

I think you’re correct. Appears not to be a recall, as such.

Another article (here) says:

​

FDA issued this safety alert on Aug. 22 calling the action a recall. However, an Edwards spokesperson told MD+DI that the device is not actually being pulled from the market and no devices are being returned as part of this action.​

 

[user 15848]

Sorry to hear, for sure there is a place for TAVR, but "for me" is not a long time solution, because eassy or not, it is still a tissue device and no matter what will need to be replaced, again...

 

[nobog]

I'm not sure that's the whole story. Some of these guys (surgeon, cardiologist) when doing a "valve in valve" will try to crack the frame of the existing bio-prosthesis using the balloon to some un-godly pressure so as to have "more room" for the TAVR, thus exceeding the balloons burst pressure (and its A LOT).

Not mak'in this stuff up - this is what is called "off label".

JK

 

[pellicle]

I'm not sure that's the whole story. Some of these guys (surgeon, cardiologist) when doing a "valve in valve" will try to crack the frame of the existing bio-prosthesis

I understood in many cases that was actually metal ...

This would appear to be an actual photograph of an interventional cardiologist discussing technique with a valve makers technical team

these guys probably uses mums spoons to try to change the tyres on their bicycles too

 

[hx77]

TAVR is always a temporary solution. One can do a TAVR over a native valve or a Biological one. I am in mid 50, ideally, TAVR+SAVR(surgical AVR)+TAVR could cover my remaining lifespan. One question I have for TAVR though is whether it will complicate SAVR? Does anyone have such information? Thanks!

John

 

[nobog]

TAVR is always a temporary solution. One can do a TAVR over a native valve or a Biological one. I am in mid 50, ideally, TAVR+SAVR(surgical AVR)+TAVR could cover my remaining lifespan. One question I have for TAVR though is whether it will complicate SAVR? Does anyone have such information? Thanks!

Yes - it is a one way deal, as you mentioned you can:
1. put a TAVR in your native valve
2. put a TAVR in a stented bio-prosthetic valve

For a TAVR there will be tissue in-growth and once it's in there - its in there. There would simply be no room for a SAVR - TAVR - TAVR.

Mid 50's ? mechanical. (my opinion)

edit, Pellicle, - your 300 psi is not that far off - we've tested the balloons to 294 psi without failure.

 

[tom in MO]

When a new device is approved, it is just a beginning. That's why the TAVR was first used on patients that would die w/o it. Since it's not a actual recall of the device, it probably is an off label application (which is legal, just not the manufacturer's or FDA's responsibility.) It becomes illegal when the manufacturer starts to market the off label application to surgeons. If it's off label, it could be the basis of a lawsuit unless the patient was informed and approved the off label application. It's your choice, bet your life, new "better technology" or "old" proven technology.

 

[pellicle]

edit, Pellicle, - your 300 psi is not that far off - we've tested the balloons to 294 psi without failure.

The materials science behind that is amazing.

 

[Protimenow]

The 'T' in TAVR is 'tissue' - Tissue Aortic Valve Replacement.

I heard of a researcher who put one in a chicken, but the poor thing only lived four years.

 

[pellicle]

I heard of a researcher who put one in a chicken, but the poor thing only lived four years.

which is quite long for many chickens

 

[LoveMyBraveHeart]

The 'T' in TAVR is 'tissue' - Tissue Aortic Valve Replacement.

I heard of a researcher who put one in a chicken, but the poor thing only lived four years.

I think it actually stands for Transcatheter Aortic Valve Replacement, but only a tissue valve can be collapsed and shoved up through your femoral artery...Will be interesting to see if future medicine comes up with a mechanical valve that can collapse like that!

 

[pellicle]

I think it actually stands for Transcatheter Aortic Valve Replacement, but only a tissue valve can be collapsed and shoved up through your femoral artery...Will be interesting to see if future medicine comes up with a mechanical valve that can collapse like that!

man I'm certain I wrote a post ... saying this ... but its not there. So "Yes" that's right
TAVR is Transcatheter and the S in SAVR is I believe "Standard"
@Admin I'd like to use this as an opportunity to please consider reviewing the order of the Preview and Post and perhaps make the Post dark not the preview dark. I'll also post this in technical support

 

[Protimenow]

Yeah. Transcatheter, Sorry.

 

[Ladybug]

So 1 week after FDA approves the valve for low risk patients, they recall the delivery system?

Doesn't inspire a lot of confidence in FDA approval process.

 

[Ladybug]

Nothing the FDA does inspires me. This is not my first go round with a failed device approved by the FDA. So, I was supposed to be getting the Sapien 3 “installed” next week, Thursday 9-5-19. A week ago I sent a
portal message to the interventional cardiologist doing this procedure. It was marked TIME SENSITIVE and referenced me needing PREDNISONE. One week had gone by and I had to make phone calls to EMORY to hit someone up-side the head with the definition of TIME SENSITIVE. I’m now going into this with my prednisone stopped 2 days prior to TAVR. So, also today I found out that I’m getting the Medtronic Core valve, instead of the Sapien 3 that they had raved was so great. Can anyone that’s had this Medtronic Core valve, tell me the good, the bad, and the ugly about what NEW NORMAL I could be walking into with this cardiac nightmare?
The entire cardiac staff at Emory St. Joseph’s treats this like a dental cleaning. I feel like a side order of fries. I feel compartmentalized and controlled. Today when I finally got the nurse navigator to answer the question of WHAT VALVE ARE WE USING...I told her I’m a research type. She sort of sarcastically said, WE KNOW. My sweet 40 yr old daughter with four kids is driving 3.5 hours with her toddler just to be with me over the weekend after the TAVR and she’s is sweating bullets. My family is glad I held my ground and insisted on getting a Sentinel calcium filter to get an edge against a stroke. (No tickey - no laundry.) Three Emory people have poo-poo’d that but the Journal of the College of American Cardioligy implores that it be made the universal standard of care. It shows stroke incidence to be higher than the
poo-poo’d one percent quoted by Emory.
Sorry this is long. I’m too symptomatic to have made two trips to the Cleveland Clinic and run this out to November.