BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT THORACIC STENT GRAFT WITH XCELERANT

    MDR report key: 2002399 · Received January 28, 2011

    Report

    Report Number
    2953200-2011-00199
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEPLOYMENT DIFFICULTIES), (VESSEL MORPHOLOGY IS UNK). EVAL, CONCLUSIONS: (VESSEL MORPHOLOGY IS UNK).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF DISSECTED THORACIC AORTA WITH A 4.6 CM THORACIC ANEURYSM. FURTHER DETAILS ON THE AORTIC MORPHOLOGY AND CAUSE OF THE EVENT WERE NOT AVAILABLE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE VALIANT STENT GRAFT COULD NOT BE SUCCESSFULLY OPENED/DEPLOYED THE FIRST TIME. THEN, THE DEVICE WAS REMOVED, AND THE STENT GRAFT WAS OPENED TO BE DEPLOYED IN VITRO. THE SAME DEVICE WAS THEN REINSERTED INTO THE PT AND THEN DEPLOYED WITHOUT ISSUES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT THORACIC STENT GRAFT WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00485379

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK