BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT SYSTEM

    MDR report key: 2820994 · Received November 6, 2012

    Report

    Report Number
    2953200-2012-02127
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFT WOULD NOT DEPLOY. THERE WERE NO DIFFICULTIES INSERTING THE DEVICE. THERE WAS NO FORCE USED IN THE ATTEMPT TO DELIVER THE DEVICE. THERE WERE NO DIFFICULTIES RETRACTING THE DEVICE INTO THE OUTER SHEATH FOR REMOVAL FROM THE PATIENT. ANOTHER DEVICE WAS SUCCESSFULLY USED TO COMPLETE THE CASE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT FINE. THIS DEVICE IS NOT MARKETED IN THE UNITED STATES HOWEVER IT IS SIMILAR TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. THE DEVICE WAS RETURNED FOR EVALUATION. THE SLIDER WAS ROTATED BUT THERE WAS NO CORRESPONDING MOVEMENT OF THE GRAFT COVER. THE DEPLOYMENT DIFFICULTIES WERE RELATED TO MANUFACTURING PROCESS DURING THE OVER-MOLD PROCESS FAILED BETWEEN THE GRAFT COVER AND THE T-TUBE COMPONENTS CAUSING THE GRAFT COVER TO BREAK OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01043945

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR