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Adverse Event Report

EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 6900
Device Problem Paravalvular leak
Event Date 01/25/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This event was reported as an explant at implant due to mitral regurgitation. No further information 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 Number6900
Baseline Device FamilyPERICARDIAL BIOPROSTHESIS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed01/01/1985
Date Ceased Marketing01/01/1986
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 Key348647
MDR Report Key359469
Event Key338792
Report Number6000002-2001-00424
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type User facility,Company Representative,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/02/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/01/2004
Device MODEL Number6900
Device LOT Number0F0808
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age4 mo
Event Location Hospital
Date Manufacturer Received10/02/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2000
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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