BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1231827 · Received November 11, 2008

    Report

    Report Number
    6000002-2008-09242
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED AT THE TIME THIS REPORT WAS SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL REGURGITATION. REPORTEDLY, THE LAST KNOT WAS IN THE A3 AREA OF THE DEVICE (NEAR THE SUTURE MARKER). THE DEVICE WOULD NOT SEAT; HOWEVER, THE SURGEON TIED THE KNOT. AFTER TYING THE KNOT, THE SURGEON HAD DIFFICULTY REMOVING THE TRICENTRIX. HE INSPECTED THE VALVE USING A DENTAL MIRROR AND HE DID NOT SEE ANY LOOSE STRINGS. REPORTEDLY, THE POSTERIOR STRUT WAS DIFFICULT TO SEE. REPORTEDLY, ONCE THE PATIENT WAS OFF PUMP, WIDE OPEN MR WAS THE RESULT. THE SURGEON REMOVED THE VALVE. THE SURGEON INSPECTED THE VALVE AND OBSERVED THAT WHEN HE TIED THE A3 AREA SUTURE DOWN, INSTEAD OF BEING DEFLECTED TO THE OUTSIDE OF THE STRUT, IT REMAINED ON THE INSIDE, ACTUALLY BENDING THE STRUT LATERALLY INTO THE VENTRICULAR WALL MUSCLE, CREATING A PERFORATION. REPORTEDLY THE DEVICE WAS REPLACED WITH A MOSAIC TO COMPLETE THE OPERATION. REPORTEDLY THE DEVICE IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900PTFX R-08A0052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention