BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1932216 · Received December 14, 2010

    Report

    Report Number
    2953200-2010-02532
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS AND CONCLUSIONS: LACK OF INFO (UNK CAUSE OF CONNECTING BAR FRACTURE).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2008. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AT A ROUTINE F/U, A FRACTURE OF THE LEFT SIDE CONNECTING BAR HAS BEEN FOUND. THE PHYSICIANS THINK THAT THE FRACTURE DOES NOT AFFECT THE INTEGRITY OF THE GRAFT AND NO INTERVENTION IS PLANNED. NO FURTHER INFO WAS PROVIDED AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00138054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK