BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL AUI STENT GRAFT

    MDR report key: 1820086 · Received August 24, 2010

    Report

    Report Number
    2953200-2010-01613
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: OTHER - PENDING DEVICE EVALUATION. EVALUATION, CONCLUSION: OTHER - PENDING DEVICE EVALUATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS UNREMARKABLE. IT WAS REPORTED THAT THE PHYSICIAN POSITIONED THE STENT GRAFT BELOW THE RENAL ARTERIES. THE PHYSICIAN WAS UNSCREWING THE RELEASE SYSTEM, HOWEVER, THE OUTER SHEATH WAS NOT RETRACTING. THE HANDLE WAS UNSCREWED TO THE END, BUT THE SHEATH DID NOT RETRACT. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY AND REPLACED BY ANOTHER TALENT DEVICE. THE DEVICE WAS RETURNED AND THE ANALYSIS IS PENDING. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. PLEASE NOTE THAT THIS DEVICE AUF2816C170AXH IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT AF2816C170XH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL AUI STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA V00173582

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK