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Adverse Event Report

EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 2700
Device Problem Paravalvular leak
Event Date 02/20/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This event was reported as aortic insufficiency and paravalvular leak; no further info was provided.

 
Manufacturer Narrative

H6: device not returned.

 
Search Alerts/Recalls

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Brand NameCARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number2700
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Manufacturer (Section F)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
allison mezzanatto
one edwards way
irvine , CA 92614
(949) 250 -2562
Device Event Key313667
MDR Report Key324199
Event Key304996
Report Number6000002-2001-00109
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 03/12/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/18/2005
Device MODEL Number2700
Device LOT Number1A0137
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age1 mo
Event Location Hospital
Date Manufacturer Received03/12/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2001
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 January 30, 2009

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