BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT XCELARANT STENT GRAFT SYSTEM

    MDR report key: 2973734 · Received July 6, 2007

    Report

    Report Number
    2953200-2007-00278
    Event Type
    Injury
    Date Received
    July 6, 2007
    Date of Event
    June 8, 2007
    Report Date
    June 13, 2007
    Manufacturer
    MEDTRONIC VASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS, (DEVICE EVAL AND FILM EVAL IS PENDING. TORTUOUS VESSELS. CONCLUSIONS: (DEVICE EVAL AND FILM EVAL IS PENDING. (REQUIRED SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A TALENT BIFURCATED STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS 5.8 CM AND THE VESSELS WERE REPORTED TO BE MODERATELY TORTUOUS AND THERE WAS CALCIFICATION AND THROMBUS IN THE AORTIC NECK. IT WAS REPORTED THAT DURING THE PROCEDURE THE PROXIMAL END OF THE STENT GRAFT DEPLOYED AND AS THE PHYSICIAN PROCEEDED TO FURTHER DEPLOY THE REMAINDER OF THE STENT GRAFT, IT FULLY DEPLOYED IN THE ANEURYSM SAC. THE PHYSICIAN ELECTED TO SEND THE PT TO SURGERY FOR SURGICAL CONVERSION. THE PT WAS SUCCESSFULLY CONVERTED TO OPEN REPAIR AND DID WELL AFTER THE PROCEDURE. NO ADDITIONAL SEQUELAE WERE REPORTED. THE DEVICE WAS RETURNED TO MEDTRONIC AND ITS EVAL IS PENDING. ADDITIONALLY, A CD OF PROCEDURE CONTAINING IMAGES OF THE IMPLANTED STENT GRAFT WAS RECEIVED AND SENT TO AN INDEPENDENT PHYSICIAN FOR REVIEW. PLEASE NOTE THAT THIS DEVICE ((B)(4)) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT ANEURX AAADVANTAGE STENT GRAFT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELARANT STENT GRAFT SYSTEM MIH MEDTRONIC VASCULAR SANTA ROSA NA V00003197

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention