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Adverse Event Report

BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 6625
Event Date 09/24/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

H3: examination of the valve in co's laboratory revealed extensive calcification throughout each leaflet which resulted in stenosis of the effective orifice area, multiple disruptions, including detachment of each cusp, as well as incomplete coaptation. Host tissue overgrowth had encroached onto each cusp, contributing to stenosis of the valve. Adherent thrombus was noted on the stent post between the right and left-coronary cusp which appeared artifactual of explant. X-ray analysis revealed calcification within the aortic wall, belly and free margin of each cusp. Stent distortion was noted and appeared artifactual of explant. The primary cause for dysfunction of this valve was determined to be due to extensive calcification. These findings would account for the symptoms noted clinically. H6: 86=x-ray analysis.

 
Event Description

This event was reported as stenosis, insufficiency and "dysfunction. " no further info provided.

 
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Brand NameCARPENTIER-EDWARDS BIOPROSTHESIS
Type of DeviceREPLACEMENT HEART VALVE
Baseline Brand NameCARPENTIER-EDWARDS BIOPROSTHESIS
Baseline Generic NameNA
Baseline Catalogue NumberNA
Baseline Model Number6625
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)
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 Key86116
MDR Report Key86923
Event Key81796
Report Number6000002-1997-00364
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Foreign,Study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/01/1988
Device MODEL Number6625
Device LOT Number4G902
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age12 yr
Event Location Hospital
Date Report TO Manufacturer03/26/1997
Date Manufacturer Received03/26/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1984
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: 05/29/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1 TRICUSPID RING 4500/31MM S/N # UNK. 09/24/1996

Database last updated on February 28, 2009

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