BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3808827 · Received May 13, 2014

    Report

    Report Number
    2953200-2014-00973
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    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 PHYSICIAN ATTEMPTED TO IMPLANT A VALIANT CAPTIVIA STENT GRAFT SYSTEM IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION. THE DIAMETER OF THE PROXIMAL AORTIC NECK AT THE LSA WAS 28-29 MM. NOTHING UNUSUAL WAS NOTED DURING DEVICE PREPARATION, AND THERE WAS NO DAMAGE TO THE PACKAGING. THE PATIENT WAS IN GOOD CONDITION PRIOR TO THE TEVAR PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN CUT DOWN TO THE LEFT FEMORAL ARTERY AND ADVANCED THE DEVICE TO THE TARGET LESION. THE DEVICE WAS POSITIONED APPROPRIATELY, AND THE FIRST THREE RINGS OF THE STENT GRAFT WERE DEPLOYED DISTAL TO THE LEFT CLAVICLE. THIS AREA OF THE ANATOMY WAS NOT REPORTED TO BE TORTUOUS. THE PHYSICIAN THEN SECURED THE GRAY FRONT GRIP OF THE DELIVERY SYSTEM WITH THE LEFT HAND. WITH THE RIGHT HAND, THE PHYSICIAN PULLED THE TRIGGER ON THE SLIDER TO QUICKLY COMPLETE DEPLOYMENT. AT THIS TIME, THE GRAY HANDLE DETACHED FROM THE DELIVERY SYSTEM AND THE STENT GRAFT WAS PULLED BACK TO THE FIRST LUMBAR VERTEBRAE WHERE IT WAS DISLODGED IN THE AORTA. AFTER CONSULTING WITH THE PATIENT¿S FAMILY, THE DECISION WAS MADE TO CONVERT THE PATIENT TO OPEN SURGICAL REPAIR AND EXPLANT THE STENT GRAFT. DURING THE SURGERY, THE THORACIC AORTIC DISSECTION RUPTURED AND THE PATIENT EXPIRED. UPON INSPECTION OF THE DELIVERY SYSTEM, THE FRONT GRIP WAS DISCONNECTED FROM THE SCREWGEAR. THERE WAS A SIGNIFICANT CURVE TO THE GRAFT COVER, WHICH WAS LIKELY DUE TO BEING RETURNED LOOSE WITHIN A GENERIC BROWN BOX. THE FRONT GRIP WAS REMOVED FROM THE DELIVERY SYSTEM AND BROKEN INTO ITS TWO HALVE TO INSPECT THE INTERNAL RIBS. BOTH OF THE THIRD RIBS ON EACH HALF WERE DAMAGED; THE THIRD RIB ON THE HALF WITHOUT THE BLUE DOT HAD A SEMI-CIRCULAR SECTION MISSING FROM THE RIB. THE COMPLAINT WAS CONFIRMED; THE FRONT GRIP WAS DETACHED FROM THE SCREWGEAR. THE CAUSE OF THE DETACHMENT WAS DUE TO DAMAGE TO THE INTERNAL RIBS OF THE FRONT GRIP. THE ROOT CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286850 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04126900

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death| R