BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2905568 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19069
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    November 9, 2012
    Report Date
    December 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. FOLLOW UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE EXPLANT WAS DUE TO ENDOCARDITIS, SOURCE IS GROUP B STREP BACTEREMIA. THE HEALTH-CARE PROVIDER ALSO NOTED THAT THE EXPLANT WAS NOT RELATED TO ANY DEVICE MALFUNCTION OR QUALITY DEFICIENCY. PER THE OPERATIVE REPORT PROVIDED, THE PATIENT WAS FOUND TO HAVE A SIGNIFICANT ENDOCARDITIS ON BOTH THE AORTIC AND VENTRICULAR SIDE OF THE AORTIC VALVE, PRINCIPALLY ON THE RIGHT NONCORONARY POST. THE AORTIC VALVE WAS EXCISED; THERE WERE VEGETATIONS. ONCE THE ANNULUS HAD BEEN DEBRIDED AND ALL PLEDGETS REMOVED, A NEW EDWARDS BIOPROSTHETIC VALVE WAS RE-IMPLANTED. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS AND WAS TAKEN TO THE SURGICAL INTENSIVE CARE UNIT. 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. IN THIS CASE, PER THE HEALTH-CARE PROVIDER, THE SOURCE OF ENDOCARDITIS IS GROUP B STREP BACTEREMIA. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12203 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R