BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO

    MDR report key: 1222047 · Received November 6, 2008

    Report

    Report Number
    2953200-2008-01011
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION. EVALUATION RESULTS: ARTERIA TRAUMA/DISSECTION/PERFORATION. DIAMETER (8 MM), SEVERELY CALCIFIED AND MODERATE TORTUOSITY. CONCLUSIONS: DIAMETER 8MM, SEVERELY CALCIFIED AND MODERATE TORTUOSITY. UNABLE TO FOLLOW-UP.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE SMALL IN DIAMETER (8 MM), SEVERELY CALCIFIED AND MODERATE TORTUOSITY. THE PATIENT WAS NOT AN OPEN SURGICAL REPAIR CANDIDATE. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO ADVANCE THE DELIVERY CATHETER TO THE INTENDED LESION SITE. UPON WITHDRAWAL OF THE DELIVERY CATHETER, THERE WAS A DROP IN THE PATIENT'S BLOOD PRESSURE. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND IT REVEALED THAT THE RIGHT EXTERNAL ILIAC ARTERY WAS PERFORATED. THE PHYSICIAN ELECTED TO PLACE AN ILIAC LIMB SUCCESSFULLY COVERING THE PERFORATED ARTERY. THE CASE WAS ENDED, THE PATIENT WILL NOT BE TREATED. THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO MIH MEDTRONIC CARDIO VASCULAR NA V00174352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention