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Adverse Event Report

EDWARDS LIFECIENCES CARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 2650
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/24/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Valve explanted after 14 years due to endocarditis. No further info was provided.

 
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Brand NameCARPENTIER-EDWARDS SUPRAANNULAR BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number2650
Baseline Device FamilyREPLACEMENT HEART VALVE
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date Ceased Marketing01/01/1986
Manufacturer (Section F)
EDWARDS LIFECIENCES
one edwards way
irvine CA 92614
Manufacturer (Section D)
EDWARDS LIFECIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
allison mezzanatto
one edwards way
irvine , CA 92614
(949) 250 -2562
Device Event Key448830
MDR Report Key459888
Event Key435673
Report Number6000002-2003-00197
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/09/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/01/1992
Device MODEL Number2650
Device LOT Number8F016X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age15 yr
Event Location Hospital
Date Manufacturer Received04/09/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/1988
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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