BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II AUI

    MDR report key: 3251061 · Received July 29, 2013

    Report

    Report Number
    2953200-2013-01448
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    June 26, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: FILMS. RESULTS, CONCLUSIONS: PROXIMAL NECK ANGULATION >60 DEGREES.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, ISCHEMIA, DEATH), (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN), CAUSED BY ANOTHER DRUG/DEVICE (HEPARIN-INDUCED THROMBOCYTOPENIA); EVALUATION, CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (OCCLUSION, ISCHEMIA, DEATH), (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    A REVIEW OF PRE-IMPLANT CTAS SHOWS AN IRREGULAR SHAPED PROXIMAL NECK FILLED WITH THROMBUS; THE NECK WAS ANGULATED APPROXIMATELY 90 DEGREES. THE AAA AND ILIAC ARTERIES WERE VERY CALCIFIED AND ALSO CONTAINED THROMBUS. THE MAXIMUM DIAMETER OF THE AAA WAS 5.3CM, AND THE RIGHT COMMON ILIAC WAS ANEURYSMAL (3CM DIAMETER). IMAGES DURING IMPLANT OR POST-IMPLANT WERE NOT PROVIDED. THE REPORTED OCCLUSION AND BLOOD CLOTTING DISORDERS COULD NOT BE ASSESSED FROM THESE IMAGES.

    Description of Event or Problem · 1

    AN ENDURANT II AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON. IT WAS REPORTED THAT THE PATIENT HAD NO DISTAL PULSES FOLLOWING THE PROCEDURE. THE GROINS WERE EXPLORED AND IT WAS DISCOVERED THAT THE ARTERIES WERE OCCLUDED WITH THROMBUS DISTAL TO THE STENT GRAFT. A THROMBECTOMY WAS PERFORMED WITH A FOGARTY CATHETER, AND PULSES WERE RESTORED. THE PATIENT WAS PLACED ON A TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP. AN ANGIOGRAM DONE THE FOLLOWING DAY SHOWED THAT THE STENT GRAFT WAS PATENT BUT EXTENSIVE SUPERFICIAL FEMORAL ARTERY DISEASE WAS PRESENT. THE TPA CATHETER WAS THEN PLACED IN THE ARM, WHERE IT SOON HAD TO BE REMOVED DUE TO CLOTTING. AT SOME POINT FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT DEVELOPED COLON ISCHEMIA. THE PATIENT WAS EVENTUALLY DIAGNOSED WITH HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), WHICH IS BELIEVED TO BE THE CAUSE OF THE CLOTTING. THE PATIENT EXPIRED 2 DAYS POST-IMPLANT. THE PHYSICIAN COMMENTED THAT THE HIT IS WHAT LEAD TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352037 ENDURANT II AUI SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04037940

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death