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Adverse Event Report

BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING   back to search results
Model Number 4600
Event Date 04/15/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

This event was reported as regurgitation. No further info provided.

 
Manufacturer Narrative

D10: carpentier-edwards duraflex mitral low pressure bioprosthesis, device implanted in tricuspid position patch implanted along the aorta. H6: 86=device not returned.

 
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Brand NameCOSGROVE-EDWARDS ANNULOPLASTY SYSTEM
Type of DeviceANNULOPLASTY RING
Baseline Brand NameCARPENTIER-EDWARDS ANNULOPLASTY SYSTEM
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number4600
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Manufacturer (Section F)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
17221 red hill avenue
irvine CA 92614
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
17221 red hill avenue
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE CORP.
17221 red hill ave.
irvine CA 92614
Manufacturer Contact
allison mezzanatto
17221 red hill avenue
irvine , CA 92614-5686
(949) 250 -2562
Device Event Key100007
MDR Report Key101586
Event Key95512
Report Number6000002-1997-00557
Device Sequence Number1
Product CodeKRH
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 05/28/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/01/1999
Device MODEL Number4600
Device LOT Number6H0715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age7 mo
Event Location Hospital
Date Manufacturer Received05/28/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/1996
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: 06/27/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1 CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSU 04/15/1997
2 EDWARDS PERICARDIAL PATCH 04/15/1997

Database last updated on February 28, 2009

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