BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3031844 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19717
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    July 23, 2012
    Report Date
    March 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE NOT RETURNED. NO FOLLOW UP DOCTOR OR SURGEON INFORMATION WAS PROVIDED. ACCORDING TO THE HOSPITAL, THE DEVICE IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE. CONCLUSION: A PARAVALVULAR LEAK IS DESCRIBED AS A LEAK OUTSIDE THE VALVE, NOT GOING THROUGH THE LEAFLETS, AND REPRESENTS REGURGITANT FLOW BETWEEN THE SEWING RING AND THE AORTIC WALL. IF HEMODYNAMICALLY SIGNIFICANT, THIS WILL REQUIRE REPLACEMENT OF THE HEART VALVE. THERE ARE SEVERAL CONTRIBUTING FACTORS TO A PARAVALVULAR LEAK, INCLUDING BUT NOT LIMITED TO, INSUFFICIENT DEBRIDEMENT OF CALCIFIED TISSUE, SURGICAL TECHNIQUE, AND PATIENT FACTORS (FRAGILE TISSUE). IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED PARAVALVULAR LEAK.

    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, THROUGH FOLLOW UP WITH THE HOSPITAL, IT WAS LEARNED A 21MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 MONTHS (8.93 MONTHS) DUE TO PARAVALVULAR LEAKAGE. THE 21MM VALVE WAS IMPLANTED ON (B)(6) 2011 AND EXPLANTED ON (B)(6) 2012. WHEN THE CHEST WAS OPENED, PARAVALVULAR LEAKAGE WAS NOT OBSERVED. IT WAS COMMENTED THAT THE PVL MUST HAVE COME FROM CALCIFICATION AROUND THE AORTIC ANNULUS. IT WAS ALSO COMMENTED THAT ALL THE CALCIFICATION WAS REMOVED AND THE 21MM VALVE WAS REPLACED WITH A MAGNA EASE 19MM VALVE, MODEL 3300TFX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136014 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R