BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1772398 · Received July 23, 2010

    Report

    Report Number
    2953200-2010-01406
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSELS; VESSEL SPASM). EVALUATION, CONCLUSIONS: (MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSELS; VESSEL SPASM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM THORACIC AORTIC ANEURYSM. ILIAC VESSELS WERE 8.5 MM IN DIAMETER, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED. IT WAS REPORTED THAT THE TALENT PROXIMAL MAIN STENT GRAFT WAS SUCCESSFULLY IMPLANTED, AND THE DELIVERY CATHETER WAS REMOVED WITHOUT ISSUES. AFTER SUCCESSFULLY DEPLOYING A DISTAL MAIN STENT GRAFT AND REMOVING ITS DELIVERY CATHETER, TRAUMA TO THE COMMON FEMORAL ARTERY OCCURRED, WITH PART OF THE ARTERY COMING OUT WITH THE DELIVERY SYSTEM. THE PHYSICIAN INSERTED A BALLOON TO STABILIZE THE PATIENT AND TREATED THE VESSEL TRAUMA WITH A 10 MM X 10 MM COVERED STENT AND A BARE METAL STENT FROM OTHER MANUFACTURERS. THE PHYSICIAN BELIEVES THAT WHEN REMOVING THE DELIVERY CATHETER, THE VESSEL HAD A SPASM, WHICH MOST LIKELY CONTRIBUTED TO THE VESSEL TRAUMA. THE PHYSICIAN THEN CONTINUED TO IMPLANT A SECOND TALENT DISTAL MAIN DEVICE; HOWEVER, DURING DEPLOYMENT, THE PROXIMAL COVERED APEX OF THE STENT GRAFT MISALIGNED DUE TO AN UNKNOWN REASON (MFR. REPORT # 2953200-2010-01407). THE STENT GRAFT WAS PULLED DOWN TO CORRECT THE MISALIGNMENT; HOWEVER, AS A RESULT, THE STENT GRAFT WAS INACCURATELY PLACED. THE PHYSICIAN ELECTED TO PLACE ANOTHER DISTAL MAIN STENT GRAFT BETWEEN THE TWO DISTAL STENT GRAFTS, AND NO ENDOLEAKS WERE EVIDENT AT THE END OF THE CASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00479375

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention