BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT THORACIC STENT GRAFT WITH XCELERANT

    MDR report key: 1922745 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02220
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS AND CONCLUSION: (CAUSE OF MISALIGNED DEPLOYED BARE SPRING IS UNKNOWN).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE AORTIC ARCH WAS TIGHT AND STEEP AND THERE WAS AN ANTERIOR TYPE OF ANEURYSM. IT WAS REPORTED THAT UPON DEPLOYMENT ONE OF THE BARE SPRINGS STARTED TO MISALIGN. THE PHYSICIAN PULLED THE DELIVERY SYSTEM DOWN IN AN ATTEMPT TO CORRECT THE MISALIGNMENT; HOWEVER, THAT DID NOT CORRECT THE MISALIGNMENT. IT IS UNKNOWN HOW FAR DOWN IT WAS PULLED, BUT THE PHYSICIAN DID NOT WANT TO PULL DOWN TOO FAR SO AS NOT TO LOSE PROXIMAL FIXATION. ANOTHER PROXIMAL MAIN WAS USED AND SUCCESSFULLY DEPLOYED RIGHT AT THE SUBCLAVIAN ARTERY. NO 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 WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00238172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK