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Adverse Event Report

EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 2800
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/22/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This event was reported as aortic valve endocarditis, aortic root abscess and suppurative material stuck to the leaflet with vegetation. The pt's native mitral was also infected with gram positive cocci. No further information was provided.

 
Manufacturer Narrative

H6: none.

 
Search Alerts/Recalls

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Brand NameCARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number2800
Baseline Device FamilyPERCARDIAL BIOPROSTHESIS
Baseline Device 510(K) Number
Baseline Device PMA NumberP860057
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed01/04/1996
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 Key316368
MDR Report Key326961
Event Key307697
Report Number6000002-2001-00127
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Study,Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/13/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/01/2003
Device MODEL Number2800
Device LOT Number9A0019
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age2 yr
Event Location Hospital
Date Manufacturer Received03/13/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/12/2001 Patient Sequence Number: 1
#TreatmentTreatment Date
1 IMPLANT OF CARPENTIER-EDWARDS PERIMOUNT 01/01/2001
2,PERICARDIAL BIOPROSTHESIS, MODEL 6900 IN THE,01/01/2001
3,MITRAL POSITION, 2001.,01/01/2001

Database last updated on December 31, 2008

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