BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2230693 · Received August 17, 2011

    Report

    Report Number
    2953200-2011-01449
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS, CONCLUSION: (SEVERELY ANGULATED AORTIC NECK), (IMPLANTATION OF THE DEVICE IN A SEVERELY ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 25 MM LONG, 23 MM IN DIAMETER, HAD SEVERE ANGULATION OF 90 DEGREES, AND HAD MILD THROMBUS AND MILD CALCIFICATION. ILIAC ARTERIES WERE LARGE IN DIAMETER AND NON-TORTUOUS WITH MILD TO MODERATE CALCIFICATION. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS INADVERTENTLY IMPLANTED LOWER THEN INTENDED DUE TO THE SEVERE ANGULATION OF THE AORTIC NECK (MFR REPORT # 2953200-2011-01448). THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A 32X32X49 ENDURANT AORTIC CUFF AT THE RENAL ARTERIES (MFR REPORT # 2953200-2011-01449). ALTHOUGH THERE WAS NO ENDOLEAK, THE PHYSICIAN ELECTED TO IMPLANT A 28X28X40 ANEURX AORTIC CUFF PREVENTIVELY BETWEEN THE ENDURANT CUFF AND THE BIFURCATED STENT GRAFT, AS THERE WAS ONLY 1 CM OF OVERLAP BETWEEN THE TWO COMPONENTS. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. AN INTERNAL REVIEW OF PRE-IMPLANT CTA'S CONFIRMED A HIGHLY ANGULATED AORTIC NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00900926

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention