BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - XCELERANT

    MDR report key: 1800029 · Received August 11, 2010

    Report

    Report Number
    2953200-2010-01532
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: AORTIC ARCH WAS SEVERELY ANGULATED, WEAKENED VESSEL WALL. 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 PATIENT FOR TREATMENT TRANSECTION IN THE THORACIC AORTA. THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND A HOARSE VOICE. THE PATIENT HAD BEEN IN A MOTOR VEHICLE ACCIDENT ABOUT 6 MONTHS AGO. THE REVIEW OF THE CT DEMONSTRATES THERE WAS A TRANSECTION OF THE AORTA. THE PHYSICIAN BELIEVES THE TRANSECTION OF THE AORTA WAS MOST LIKELY DUE TO THE 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. (MFR 2953200-2010-01531) THE PHYSICIAN ELECTED TO USE A SECOND DEVICE AND THE SECOND DEVICE ALSO MISALIGNED HOWEVER, WAS UNABLE TO CORRECT THE MISALIGNED DEPLOYMENT. (MFR 2953200-2010-01532). THERE WAS A PROXIMAL SEAL AND THE DECISION WAS MADE NOT TO FURTHER INTERVENE AND TO MONITOR THE PATIENT. 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 - XCELERANT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00428547

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR