BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1170251 · Received September 11, 2008

    Report

    Report Number
    2953200-2008-00789
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MEDTRONIC CARIDOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULT AND CONCLUSIONS: (DEVICE NOT RETURNED FOR EVALUATION), OTHER (TAPERED TIP/DELIVERY CATHETER), (SEVERELY TORTUOUS ILIAC ARTERY).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS SEVERELY TORTUOUS ILIAC ARTERY. IT WAS REPORTED THAT THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED HOWEVER UPON REMOVAL OF THE DELIVERY CATHETER THE BULLET GOT CAUGHT IN THE LAST STENT RING OF THE STENT GRAFT. THE PHYSICIAN WAS ABLE TO MANIPULATE THE DEVICE TO REMOVE IT FROM THE PT. BY INFLATING A BALLOON, TWISTING AND PUSHING A FEW TIMES AND THE DEVICE WAS ABLE TO BE PULLED BACK INTO THE DELIVERY CATHETER AND REMOVED FROM THE PT. NO INTERVENTION WAS REQUIRED AND THE PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARIDOVASCULAR NA V00101217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK