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Adverse Event Report

BAXTER HEALTHCARE CORP. EDWARDS CVS DIVISION CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE   back to search results
Model Number 2625
Event Date 04/15/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

F1: user facility. 2200="deterioration", h6: 86=device not returned.

 
Event Description

This event was reported as "deterioration", calcification and insufficiency. 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 Number2625
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 DIVISION
17221 red hill avenue
irvine CA 92614
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. EDWARDS CVS DIVISION
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 Key100272
MDR Report Key101888
Event Key95776
Report Number6000002-1997-00551
Device Sequence Number1
Product CodeLWR
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 05/27/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number2625
Device LOT Number9A036
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age18 yr
Event Location Hospital
Date Manufacturer Received05/27/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/1979
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 February 28, 2009

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