BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3163418 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20317
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PROSTHETIC VALVE DEHISCENCE MAY OCCUR EARLY OR LATE. WHEN IT OCCURS IN THE EARLY POST-OPERATIVE PERIOD, IT IS TYPICALLY A RESULT OF AN INADEQUATE VALVE REPAIR IN COMBINATION WITH FRIABLE MYOCARDIAL TISSUE. IN THIS CASE, SUTURES WERE NOTED TO BE PULLING THROUGH THE ANNULUS; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 18 DAYS DUE TO DEHISCENCE OF THE PROSTHETIC VALVE. PER THE OP REPORT, THE PATIENT INITIALLY HAD DONE WELL POST-IMPLANT OF THIS DEVICE. APPROXIMATELY 4 OR 5 DAYS POSTOP, HE HAD AN EPISODE OF HYPOTENSION AND IT WAS INITIALLY THOUGHT THAT HIS HYPOTENSION HAD CAUSED SOME END-ORGAN DAMAGE WITH APPROXIMATELY 12-14 HOURS OF PRESSURES IN THE 80S. THE PATIENT ACTUALLY WENT INTO RENAL FAILURE REQUIRING HEMODIALYSIS AND SEEMED TO BE GETTING BETTER. THE PATIENT ALSO HAD AN EVENT OF THROMBOTIC THROMBOCYTOPENIA, IN WHICH HE RECOVERED. SUBSEQUENTLY, AN ECHOCARDIOGRAM WAS PERFORMED FOR THE PATIENT'S CARDIAC FUNCTION, WHICH DEMONSTRATED DEHISCENCE OF THE PROSTHETIC AORTIC VALVE IN THE RIGHT CORONARY LEAFLET AREA. THEREFORE, REDO-AORTIC VALVE REPLACEMENT WAS SCHEDULED. DURING EXPLANTATION OF THE VALVE, IT WAS NOTED THAT 1 OR 2 SUTURES PULLED THROUGH THE ANNULUS. APPROXIMATELY A 7 MM TEAR IN THE ANNULUS IN THE AREA OF THE RIGHT CORONARY WAS OBSERVED WHERE THE DEHISCENCE HAD OCCURRED. THIS WAS TRIMMED OUT AND A 23 MM EDWARDS VALVE WAS IMPLANTED. THE DEVICE SEATED VERY EASILY AND THERE WAS NO EVIDENCE OF THE SUTURES PULLING THROUGH THE ANNULUS. THERE WAS GOOD AORTIC VALVE FUNCTION AND NO EVIDENCE OF PERIVALVULAR LEAK ON TEE AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264230 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-12H3000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R