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Adverse Event Report

EDWARDS LIFESCIENCES CRPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 6625LP
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/21/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This event was reported as valve explanted after one year due to echo showing restriction of 2 out of 3 leaflets: left atrial thrombus and possible thrombus on valve. Left ventricular function decreased; ejection fraction, 30%. No further information provided.

 
Manufacturer Narrative

H6. Method: device not returned.

 
Search Alerts/Recalls

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Brand NameCRPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number6625LP
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 Key373379
MDR Report Key384327
Event Key362860
Report Number6000002-2002-00127
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 02/18/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/01/2004
Device MODEL Number6625LP
Device LOT Number0K1470
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age14 mo
Event Location Hospital
Date Manufacturer Received02/18/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2000
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 December 31, 2008

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