BEUDAMED
    FDA Adverse Event Death Summary report: N

    WORLD MEDICAL TALENT VARIETY

    MDR report key: 276963 · Received May 9, 2000

    Report

    Report Number
    MW1018824
    Event Type
    Death
    Date Received
    May 9, 2000
    Date of Event
    May 3, 2000
    Report Date
    May 5, 2000
    Manufacturer
    WORLD MEDICAL MFG CORP.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAD BIFURCATED ABDOMINAL AORTIC TALENT ENDOGRAFT FOR ABDOMINAL AORTIC ANEURYSM IN 1998. PT WAS ADMITTED WITH LEAKING ABDOMINAL AORTIC ANEURYSM STATUS POST STENT IN 1998. IN 2000 ANGIOGRAM REVEALED A LARGE TYPE I ENDOLEAK AT THE POSTEROLATERAL ASPECT OF A TALENT AORTOILIAC STENT GRAFT, AND ALSO SEVERE ECCENTRIC STENOSIS AT THE JUNCTION OF THE RIGHT EXTERNAL ILIAC AND RIGHT COMMON FEMORAL ARTERY, POSSIBLY IATROGENIC RELATED TO ARTERIAL PUNCTURE. THE LATTER WAS TREATED WITH DEPLOYMENT OF A 7MM 4CM PALMAZ STENT WITH SUBSEQUENT ARTERIOGRAM SHOWING GOOD ANATOMICAL RESULT AND NO RESIDUAL STENOSIS. PT WAS SCHEDULED FOR A SURGERY BUT THE DAY BEFORE AT 18:44 PT HAD BRADYCARDIA IN 40'S AND STOPPED BREATHING. CPR WAS STARTED AND PT DIED. DEVICE PLACED ON COMPASSIONATE BASIS AT ANOTHER HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORLD MEDICAL TALENT VARIETY TALLENT ENDOVASCULAR STENT MIH WORLD MEDICAL MFG CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death