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Adverse Event Report

EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 3000
Device Problem Unknown (for use when the device problem is not known)
Event Date 04/25/2004
Event Type  Injury  
Event Description

This valve was reportedly explanted after almost two months implant duration due to endocarditis and was replaced with another valve. The valve is not being returned for evaluation. No further information available.

 
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Brand NameCARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number3000
Baseline Device FamilyPERICARDIAL BIOPROSTHESIS
Baseline Device 510(K) Number
Baseline Device PMA NumberK860057
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed11/14/2003
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 Key522834
MDR Report Key533563
Event Key503043
Report Number6000002-2004-00171
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/08/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2004
Is This An Adverse Event Report? No
Device Operator Health Professional
Device EXPIRATION Date12/08/2007
Device MODEL Number3000
Device LOT NumberAX74957
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/25/2004
Device Age4 mo
Event Location Hospital
Date Manufacturer Received06/08/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2003
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?
Type of Device Usage Initial

Database last updated on January 30, 2009

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