BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2133040 · Received June 17, 2011

    Report

    Report Number
    2015691-2011-15747
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BIOPROSTHESIS VEGETATION. .EVALUATION METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SUBJECT SERIAL NUMBER WAS TRACED BACK TO ITS STERILITY LOT; THE COMPLAINT DATABASE INDICATES NO OTHER RELATED INFECTION/ENDOCARDITIS REPORTS RECEIVED FOR ANY DEVICES PROCESSED UNDER THE SAME STERILITY LOT. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS LEARNED THAT THE EDWARDS' VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 MONTHS AND REPLACED WITH A SAME MODEL EDWARDS VALVE. THROUGH FOLLOW-UP, IT WAS REPORTED THAT THE REASON FOR EXPLANT WAS DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS, COAGULASE-NEGATIVE STAPHYLOCOCCUS EPIDERMIDIS. OPERATIVE REPORT INDICATES THERE WERE LARGE VEGETATIONS ENCOMPASSING THE VALVE AND ANNULUS AND THERE WAS ALSO AN UNSUSPECTED ANTERIOR WALL AORTIC ANEURYSM THAT WAS POSSIBLY A PSEUDOANEURYSM WITH VEGETATIONS NOTED. THE SURGEON INDICATED THAT SOURCE OF INFECTION IS UNKNOWN, AND THE REASON FOR EXPLANT IS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10J2491

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention