BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT

    MDR report key: 4161864 · Received October 10, 2014

    Report

    Report Number
    2953200-2014-02028
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT DURING THE SURGERY, EXTERNAL SHEATH OF THE DEVICE COULD NOT BE RETRACTED, THE BLUE HAND SWITCH WAS STUCK AFTER THE PHYSICIAN REVOLVED IT 3CM ALONG THREAD. THE PHYSICIAN PRESSED QUICK RELEASE BUTTON BUT ALSO FAILED. THE PHYSICIAN REMOVED THE DEVICE AND CHANGED A NEW VALIANT STENT GRAFT WAS USED TO COMPLETE THE SURGERY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: UPON INSPECTION OF THE DEVICE, THE EXTERNAL SLIDER WAS 27 MM FROM THE FRONT GRIP, RESULTING IN A 28 MM GAP BETWEEN THE TAPERED TIP AND GRAFT COVER. THE STENT GRAFT WAS PARTIALLY DEPLOYED, WITH THE BARE SPRING AND FIRST COVERED STENT EXPOSED. 7 OF THE 8 STENTS WERE NO LONGER CONSTRAINED WITHIN THE CAPTURE FITTING. THERE WAS A MINOR KINK IN THE GRAFT COVER 736 MM FROM THE DISTAL END OF THE GRAFT COVER. THE REST OF THE DEVICE WAS UNREMARKABLE. THE EXTERNAL SLIDER WAS ROTATED WITH MINIMAL RESISTANCE AND RESULTED IN CORRESPONDING MOVEMENT IN THE GRAFT COVER. THE QUICK RELEASE TRIGGER WAS ALSO USED SUCCESSFULLY TO DEPLOY THE STENT GRAFT. NO ABNORMALITIES WERE NOTED DURING DEPLOYMENT. INSPECTION OF THE STENT GRAFT REVEALED NO ANOMALIES. THE DELIVERY SYSTEM WAS BROKEN DOWN TO REVEAL THE INTERNAL COMPONENTS; ALL INTERNAL COMPONENTS FUNCTIONED AS INTENDED AND NO ABNORMALITIES WERE NOTED. THE EVENT COULD NOT BE CONFIRMED SINCE IT TOOK PLACE IN-VIVO. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; BESIDES THE PARTIALLY DEPLOYED STENT GRAFT, THE DEVICE WAS UNREMARKABLE AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639638 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04654385

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR