BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3870852 · Received June 12, 2014

    Report

    Report Number
    2015691-2014-01379
    Event Type
    Death
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS PATIENT EXPERIENCED STENOSIS OF HER EDWARDS VALVE. MANY FACTORS CAN CONTRIBUTE TO THE ONSET OF BIOPROSTHETIC VALVE STENOSIS, INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THERE IS ALSO NO INFORMATION SUGGESTING THAT THE EDWARDS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS (B)(6) FEMALE PATIENT EXPERIENCED BIOPROSTHETIC AORTIC STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 14 YEARS. COMORBIDITIES INCLUDED DIABETES, HYPERTENSION, MYOCARDIAL INFARCTION, CAD; S/P CABG AND AVR, NYHA CLASS IV AND PVD. PATIENT WAS SCHEDULED TO UNDERGO TAVR WITHIN THE EXISTING EDWARDS VALVE; HOWEVER, IT WAS LEARNED THE PATIENT EXPIRED. THE EXACT CAUSE OF DEATH IS UNKNOWN. THE PATIENT WAS REPORTED TO HAVE A PEA AND WAS ALSO UNDER TREATMENT FOR C DIFFICILE. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346974 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R