BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2230633 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01438
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK, CONVERSION TO OPEN REPAIR), (AORTIC NECK ANGULATION). CONCLUSION: (AORTIC NECK ANGULATION).

    Description of Event or Problem · 1

    A MEDTRONIC ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL ANEURYSM ON AN UNK DATE. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. CURRENTLY, THE PROXIMAL AORTIC NECK IS REPORTED TO BE ANGULATED. IT WAS REPORTED THAT THE PT RETURNED FOR A F/U AND, ALTHOUGH THERE WAS NO ENDOLEAK OR ANEURYSM ENLARGEMENT, THE PHYSICIAN THOUGHT THAT THERE SEEMED TO BE TOO MUCH SPACE BETWEEN THE STENT GRAFT AND THE RENAL ARTERIES (MFR REPORT # 2953200-2011-01437). THE PHYSICIAN ELECTED TO IMPLANT TWO ENDURANT CUFFS SUCCESSFULLY. LATER THE NIGHT OF THE INTERVENTION, THE PT WAS HYPOTENSIVE, AND THE HEMOGLOBIN AND HEMATOCRIT LEVELS DROPPED; A CTA SHOWED A POSSIBLE ENDOLEAK FROM THE POSTERIOR WALL OF THE ANEURYSM. THE PHYSICIAN ELECTED TO EXPLANT ONE OF THE ENDURANT CUFFS (MFR REPORT # 2953200-2011-01438) VIA AN OPEN REPAIR WITH A DACRON GRAFT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00567746

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention