BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2960138 · Received February 13, 2013

    Report

    Report Number
    2015691-2013-19271
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 2800 WHICH IS MARKETED IN THE U.S. METHOD: DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROGRESS. UNKNOWN IF DEVICE WILL BE RETURNED. NO ALLEGATION OF DEVICE MALFUNCTION. NO PATIENT INFORMATION PROVIDED. NO STATUS OF PATIENT CONDITION AVAILABLE. NO FOLLOW UP DOCTOR OR SURGEON INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    SALES REP LEARNED THROUGH FOLLOW UP WITH THE SURGEON THAT THIS EXPLANT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE. THE SURGEON INDICATED THAT THE SOURCE AND TYPE OF INFECTION WAS NOT FROM THE VALVE AND THE SURGEON DISASSOCIATED THE DEVICE. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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

    IN THIS CASE, A 23MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 YEARS, 11 MONTHS (35.93 MONTHS) DUE TO UNKNOWN REASONS. THE 23MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 25MM MAGNA EASE MITRAL VALVE, MODEL 3300TFX-25MM. NO FURTHER DETAILS WERE PROVIDED. INFORMATION WAS LEARNED THROUGH (B)(6) IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62388 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R