BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT XCELERANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1052517 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00347
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 29, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DELIVERY SYSTEM WAS RECEIVED AND ITS EVALUATION HAS BEEN COMPLETED. THE HANDLE WAS RECEIVED DISASSEMBLED. THERE WERE MULTIPLE SEVERE KINKS AT 9 MM (AT TAPERED TIP BULB), 45 MM, 72MM, 94MM, 123MM AND 180MM. THE QUICK RELEASE BUTTON WAS DISCONNECTED. THE REMAINDER OF THE DELIVERY SYSTEM APPEARED UNREMARKABLE. A MOCK DEPLOYMENT WAS PERFORMED AND THE STENT GRAFT DEPLOYED NORMALLY. THE QUICK RELEASE BUTTON FUNCTIONED AS EXPECTED.

    Description of Event or Problem · 1

    A 26MM DIAMETER X 16 MM DIAMETER X 170 MM LENGTH TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 39 MONTHS AGO. THE DIAMETER OF THE AORTIC NECK AT THE TIME OF IMPLANT WAS 22 MM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. THE PROCEDURE WAS UNEVENTFUL WITH SUCCESSFUL ANEURYSM REPAIR. IT WAS REPORTED THAT DURING AN ANNUAL CT SCAN APPROXIMATELY 3 YEARS POST IMPLANT THERE WAS INCREASE IN DIAMETER OF THE PROXIMAL AORTA FROM 22 MM TO 26 MM. THERE WAS 70 MM CAUDAL MIGRATION OF THE BIFURCATED STENT GRAFT AND A TYPE 1 ENDOLEAK WAS PRESENT (SEE MFR# 2953200-2008-00346). THE PT WAS BROUGHT BACK THE NEXT MONTH TO ATTEMPT REPAIR WITH A TALENT BIFURCATED STENT GRAFT ON THE XCELERANT DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS ABLE TO TRACK THROUGH THE EXISTING BIFURCATED STENT GRAFT; HOWEVER, ONCE IT WAS WITHIN THE STENT GRAFT TRACKING, IT WAS DIFFICULT TO TRACK AND IT WAS NOT POSSIBLE TO DEPLOY THE STENT GRAFT USING THE HANDLE. THE HANDLE WAS DISASSEMBLED IN ORDER TO ATTEMPT MANUAL DEPLOYMENT WHICH ALSO PROVED UNSUCCESSFUL. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PT AND FOUR MAJOR KINKS WERE VISIBLE REPRESENTING THE LOCATION OF THE STENT GRAFT. A SECOND ATTEMPT WAS MADE WITH AN XCELERANT AORTO-UNI-ILIAC DEVICE WHICH WAS THE SAME LENGTH AS THE DEVICE USED IN THE PREVIOUS ATTEMPT. THE DELIVERY SYSTEM WAS ABLE TO TRACK USING SUPER STIFF WIRES. AGAIN THE STENT GRAFT WAS UNABLE TO DEPLOY (SEE MFR# 2953200-2008-00348). IT WAS REMOVED FROM THE PT. THERE WERE FOUR MAJOR KINKS ON THE DELIVERY SYSTEM. PLEASE NOTE THAT THE MODEL NUMBER AF3018C170AX IS NOT DISTRIBUTED IN THE UNITED STATES. A THIRD ATTEMPT WAS MADE WITH A SHORTER XCELERANT AORTO-UNI-ILIAC DEVICE. THE DELIVERY SYSTEM WAS ABLE TO TRACK USING SUPER STIFF WIRES; HOWEVER, AS IN THE 2 PREVIOUS ATTEMPTS THE STENT GRAFT WAS UNABLE TO DEPLOY (SEE MFR# 2953200-2008-00349). THE DELIVERY SYSTEM WAS REMOVED FROM THE PT AND 3 MAJOR KINKS WERE FOUND. THE PROCEDURE WAS ENDED WITH THE PT UNTREATED AND THE DECISION WAS TO PERFORM THE ENDOVASCULAR REPAIR WITH ANOTHER MANUFACTURER'S DEVICE AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELERANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00029490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK