BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT

    MDR report key: 1801260 · Received August 11, 2010

    Report

    Report Number
    2953200-2010-01531
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS AND CONCLUSIONS: AORTIC ARCH WAS SEVERELY ANGULATED, WEAKENED VESSEL WALL.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PT FOR TREATMENT TRANSECTION IN THE THORACIC AORTA. THE PT PRESENTED EMERGENTLY WITH CHEST PAIN AND A HOARSE VOICE. THE PT HAD BEEN IN A MOTOR VEHICLE ACCIDENT ABOUT 6 MONTHS AGO. THE REVIEW OF THE CT DEMONSTRATES THERE WAS A TRANSECT OF THE AORTA. THE PHYSICIAN BELIEVES THE TRANSECTION OF THE AORTA WAS MOST LIKELY DUE TO A MOTOR VEHICLE ACCIDENT, WEAKENING THE VESSEL WALL. THE AORTIC ARCH WAS MODERATELY ANGULATED. IT WAS REPORTED THAT THE PROXIMAL MAIN DEVICE WAS PLACED AT THE LEFT SUBCLAVIAN AND THE APEX OF THE STENT GRAFT MISALIGNED DURING DEPLOYMENT. THE PHYSICIAN WAS ABLE TO CORRECT THE MISALIGNMENT OF THE STENT GRAFT, BY PULLING THE STENT GRAFT DOWN, HOWEVER, THIS RESULTED IN INACCURATE DELIVERY OF THE DEVICE. THE PHYSICIAN ELECTED TO USE A SECOND DEVICE AND THE SECOND DEVICE ALSO MISALIGNED, HOWEVER, WAS UNABLE TO CORRECT THE MISALIGNMENT DEPLOYMENT (MFR 2953200-2010-015320). THERE WAS A PROXIMAL SEAL AND THE DECISION WAS MADE NOT TO FURTHER INTERVENE AND TO MONITOR THE PT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00214352

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention