BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT THORACIC STENT GRAFT SYSTEM WITH XCELERANT

    MDR report key: 1181405 · Received September 24, 2008

    Report

    Report Number
    2953200-2008-00853
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: OTHER (QUICK DISCONNECTION BUTTON). LACK OF INFORMATION (DEVICE WAS DISCARDED).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE QUICK RELEASE BUTTON AT THE BACK END OF THE DELIVERY SYSTEM REQUIRED TO BE RECONNECTED AFTER WHICH THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED WITH NO COMPLICATION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE DELIVERY SYSTEM WAS DISCARDED AFTER THE PROCEDURE. PLEASE NOTE THAT THIS MODEL NUMBER TF3232C150X IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, THE DELIVERY SYSTEM IS SIMILAR TO THE TALENT THORACIC ON XCELERANT DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT THORACIC STENT GRAFT SYSTEM WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00003944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK