BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3191684 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20441
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    September 19, 2012
    Report Date
    May 31, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE SUBJECT DEVICE HAS BEEN DISCARDED BY THE HEALTH-CARE PROVIDER, THEREFORE, THE DEVICE CANNOT BE ASSESSED FOR ANY DEFICIENCY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. PARAVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE. IT MAY OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE AT THE ANNULUS . THE MOST COMMON REASON FOR PVL IS INADEQUATE DEBRIDEMENT OF A CALCIFIED ANNULUS AND IS NOT A RESULT OF DEVICE MALFUNCTION. IN THIS CASE, PER THE FOLLOW-UP WITH HEALTH-CARE PROFESSIONAL, "THE PVL WAS CAUSED BY A SURGICAL ERROR AND WAS NOT PRODUCT RELATED." NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 MONTHS. BASED ON OUR FOLLOW-UP, IT WAS LEARNED THAT THE EXPLANT WAS DUE TO PERIVALVULAR LEAK (PVL) CAUSED BY A SURGICAL ERROR AND WAS NOT PRODUCT RELATED. PER THE HEALTH-CARE PROVIDER, "THE VALVE WAS DISCARDED AS IT WAS NOT AT FAULT." THE SUBJECT DEVICE WAS REPLACED WITH A NON-EDWARDS VALVE. NO OTHER DETAILS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290128 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 S-11F2268

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R