AW: [HSF] Valve Dysfunction

[Nasser F. Abou'Seada]

I totally agree with you Prasanna 
believe it or not ..... I have a record of many different failures in
prosthetic valves ... this one was fatal ... ... kept on my computer data
base .... yet ... can't but to inquire from the local distributor of the
prosthesis ....  
Reasons ?? 
Things are different here in this part of the world .... the direct contact
would be with a distributor .... Almost always a trade company with far from
scientific background .... let away understanding the mechanics or design of
the prosthesis .... ..... whose med rep understands nothing .... let apart
giving you an explanation ..... you can't even think about making a
complaint to them .... let apart asking for company engineers to inspect or
evaluate a faulty prosthesis ... or technique -as Ani explained- 
You can always be sure of the always valid statement .... "Never ever ever
ever" ..... 
Another point that has to be taken into consideration is.....
CONFIDENTIALITY ..... a sword that is easily raised in one's face once you
report an incident .. !!!! ... by Law .... it has to be reported to the
responsible board ... who has got the right to report the incident and ask
for investigations ..... or just "deal" with it 

Don't get furious like Hal .... the Board is made up of senior scientific
personnel .... though they have seen nothing .... it will be their word to
determine how things go ...... 
....
Hal: .... Believe me ... I'm happy for your words .... I've been to the DA 3
times ....  Taking cases officially to the Dean's office 4 times ..... huh
.... any more to be said ???? .... no need to elaborate on the results ....
However ... I just remember C. Duran and his "SPANISH" comments on similar
circumstances .... 

A decision to stop dealing with one supplier .... substituting another one
is always made .... and ....??? ... 

I totally agree with your comments ..... 



NFA 

> From: prasannasimha
> I agree with reporting but unfortunately the "We have never heard of
> this before"  has happened to us. That is also true. It may be that
> these events don't get reported "up the ladder" and unspoken hushing up
> maybe done tacitly at lower levels if it is not a "code of silence"
> 
> Prasanna
> 
> Ben Bidstrup wrote:
> > To support what Bob has stated, each valve has a history. The serial
> > number can usually be retrieved by Xraying the valve and the audit
> > trail looked at. This gives the tolerances of the leaflet fit etc etc.
> > Now, with the pressure from regulatory bodies any funny business is
> > likely to be more damaging than describing a problem.
> > After all, we are replacing what is essentially a well designed valve
> > that has degenerated be it by disease or dint of time with a man made
> > device.
> > We, like our patients expect perfection, but man ain't perfect. We go
> > close but we also err.
> > How does 1 failure in say 100,000 implants compare with the multitudes
> > of stents that have failed with withdrawal of ADP receptor blockade.
> > We are also responsible for our own actions, so putting a high profile
> > valve of any description into a small LV cavity must be viewed with
> > suspicion. We learnt that with early versions of tissue valves and in
> > some cases with the Starr-Edwards.
> >
> >
> >> Nasser,
> >>
> >> (who would have thought that I do hear from you so soon after
> >> Damascus?)  I think a lot has been said already (as Alvarez`quoted
> >> nicely) and the discussion jumped from the  tragedy with a blocked
> >> valve over emergency EC to LV rupture with tissue valves.
> >>
> >> I think we have to separate the problem and I want to comment only
> >> your  initial sad experience: as you have heard personally,  I have
> >> presented the 10yrs data on the ON-X valve and have never ever seen a
> >> blocked valve in aortic position,  which is impossible due to the
> >> ingenious design of that valve. You know that the leaflets are in
> >> what I call a tube and there is nothing like a hinge mechanism like
> >> the opening of a door, but the leaflet slide on a ramp up and down
> >> the housing and simultaneously clean it. I am not aware of anybody
> >> who had this sort of complication with an  ON-X valve.
> >>
> >> Also the ingrowth of pannus (as discussed some weeks before) is
> >> impossible, at least not in aortic position.
> >>
> >> So one should simply look at different valves at the same time and
> >> decide. Same is true for biological valves and the height and
> >> morphology of the struts; but I am not going in to details here. I do
> >> believe nearly all of the postings on this matter. Maybe we surgeons
> >> should rethink the position of the struts, when more colleagues have
> >> seen LV rupture at the 10 o'clock position?
> >>
> >> I would also repeat John Fleges comment in never giving any  valve
> >> out of your hands; I do have negative experiences with 2 companies
> >> some 10 years ago. One valve is not on the market anymore.  Let
> >> somebody inspect the valves in your presence and let also somebody
> >> else have a look to have several opinions and make up your mind. A
> >> cooperation with the Technical University in Cairo and its department
> >> for material testing would be great, if there are interested engineers?
> >>
> >> Marhaba, Axel
> >> ( Laczkovics, Germany)
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