BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1843542 · Received September 22, 2010

    Report

    Report Number
    2953200-2010-01788
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: ARTERIAL AND VENOUS OCCLUSION, ANGULATED AORTA AND AORTIC NECK. CONCLUSION: ANGULATED AORTA AND AORTIC NECK.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS SEVERLY ANGULATED AND 6 CM DISTALLY THE AORTA HAD ANOTHER ANGLE. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED, THE UN-STENTED SEGMENT WAS KINKED AND IT WAS 60% OCCLUDED. AN ANEURX ILIAC EXTENSION LIMB WAS IMPLANTED IN THE UN-STENTED SEGMENT AND RESOLVED THE KINK WITH GOOD FLOW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00506316

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention