BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2173974 · Received July 24, 2011

    Report

    Report Number
    2015691-2011-15913
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. AS THE SUBJECT DEVICE WAS NOT RETURNED, NO EVALUATION CAN BE PERFORMED AT THIS TIME. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION, OR 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. IN THIS CASE, IT WAS LEARNED THAT THE EDWARDS' AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 MONTHS. THROUGH FOLLOW-UP, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED DUE TO AORTIC STENOSIS, INSUFFICIENCY, AND PARAVALVULAR LEAK. OPERATIVE REPORT FINDINGS INDICATE," EXAMINATION OF THE BIOPROSTHETIC VALVE SHOWED TWO AREAS OF PARAVALVULAR LEAK INVOLVING THE COMMISSURE AREA BETWEEN THE RIGHT AND NONCORONARY ASPECT OF THE AORTIC VALVE ANNULUS AND ALSO INVOLVING THE LEFT AND NONCORONARY COMMISSURE ASPECT OF THE AORTIC VALVE ANNULUS. HERE, THE BIOPROSTHETIC AORTIC VALVE WAS NOT SEATED DIRECTLY DOWN TO THE AORTIC ANNULUS, RESULTING IN PARAVALVULAR REGURGITATION. ALL OTHER AREAS OF THE VALVE WERE WELL APPROXIMATED TO THE AORTIC VALVE ANNULUS. THE LEAFLETS OF THE AORTIC VALVE APPEARED ENTIRELY NORMAL. THERE WAS NO EVIDENCE TO SUGGEST ACTIVE OR PAST ENDOCARDITIS. THE BIOPROSTHETIC AORTIC VALVE WAS REMOVED WITHOUT DIFFICULTY". THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10F1541

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R METFORMIN| LOPRESSOR| COUMADIN