BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4006946 · Received August 13, 2014

    Report

    Report Number
    2015691-2014-01859
    Event Type
    Death
    Date Received
    August 13, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE WHETHER DEVICE 1 OR DEVICE 2 CONTRIBUTED TO THE REPORTED "HEART RUPTURE." HOWEVER, THE REPORTED SIZING ISSUE MAY HAVE CONTRIBUTED TO THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MFR REPORT #2015691-2014-01862 WAS FILED FOR DEVICE 2.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT TWO MITRAL DEVICES [DEVICE 1 = 29MM, DEVICE 2 = 27MM] WERE EXPLANTED AT IMPLANT DUE TO A SIZING ISSUE RESULTING IN REGURGITATION AND "HEART RUPTURE." A THIRD DEVICE (25MM) WAS SUCCESSFULLY IMPLANTED, ALTHOUGH IT WAS REPORTED THE PATIENT EXPIRED IN THE OPERATING ROOM WHILE TRYING TO WEAN FROM CARDIOPULMONARY BYPASS. CAUSE OF DEATH WAS REPORTED AS BLEEDING AND EXTENDED BYPASS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482020 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| R