BEUDAMED
    FDA Adverse Event Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2223776 · Received August 25, 2011

    Report

    Report Number
    2015691-2011-16107
    Date Received
    August 25, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED, WILL NOT BE RETURNED.ADDITIONAL MANUFACTURER NARRATIVE:THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED SUCH AS THE REASON FOR EXPLANT, OPERATIVE FINDINGS, AND DEVICE STATUS; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT.THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    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. INT HIS CASE, IT WAS LEARNED THAT THE 21MM AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AT IMPLANT, AND REPLACED WITH SAME MODEL, 23MM VALVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO A PARAVALVULAR LEAK. THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS NOT RELATED TO A DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING OPERATIVE FINDINGS DUE TO PATIENT PRIVACY REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-11B0583

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R