BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 1111731 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00676
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION REQUIRED. EVAL RESULTS: (OCCLUSION), (SEVERE TORTUOSITY OF THE ILIAC LIMB). CONCLUSION: (SEVERE TORTUOSITY OF THE ILIAC LIMB).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE TORTUOSITY, MILD CALCIFICATION AND MILD ANGULATION OF THE SHORT AORTIC NECK. IT WAS REPORTED THAT THE CONTRA LATERAL LIMB WAS BOWING/CURVING AROUND. IT WAS REPORTED TWO DAYS AFTER DEPLOYMENT OF THE IPSILATERAL LIMB STENT GRAFT WAS DEPRESSED DUE TO THE CONTRA LIMB PUSHING OVER ON THE CONTRA LIMB WHICH WAS UNSUPPORTED. THE PHYSICIAN ELECTED TO PLACE TWO ILIAC LIMBS, ONE LIMB ON EACH SIDE FOR REINFORCEMENT OF THE STENT GRAFT. THE PHYSICIAN BELIEVES THE SEVERE TORTUOSITY OF THE ILIAC LIMB RESULTED IN THE ILIAC LIMB BOWING CAUSING VESSEL OCCLUSION. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00114523

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention