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Adverse Event Report

EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 6900P29MM
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 07/12/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Valve showed large central jet on echo, after implant; opened heart and found one strut bent. Surgeon un-bent strut and reimplanted valve. Valve remains implanted. No further info was provided.

 
Manufacturer Narrative

H6: device not returned (remains implanted).

 
Search Alerts/Recalls

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Brand NameCARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
Baseline Generic NameREPLACEMENT HEART VALVE
Baseline Catalogue NumberNA
Baseline Model Number6900P29MM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
allison mezzanatto
one edwards way
irvine , CA 92614
(949) 250 -2562
Device Event Key529478
MDR Report Key540170
Event Key512904
Report Number6000002-2004-00225
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 07/19/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/01/2008
Device MODEL Number6900P29MM
Device LOT Number4B0303
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age5 mo
Event Location Hospital
Date Manufacturer Received07/19/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 06, 2009

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