BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3813143 · Received May 15, 2014

    Report

    Report Number
    2953200-2014-00990
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT FOR AN EMERGENT RUPTURE OF A 38MM THORACIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT AFTER THE DEVICE WAS OPENED A GAP WAS IDENTIFIED BETWEEN THE NOSE CONE AND THE GRAFT COVER OF THE DELIVERY SYSTEM, ABOUT 4MM. UPON RECOGNIZING THE DISCREPANCY WITH THE DEVICE THE PHYSICIAN DECIDED NOT USE THE DEVICE SINCE THIS MIGHT CAUSE DAMAGE TO THE VESSEL DURING DELIVERY. THE DEVICE WAS NEVER INTRODUCED INTO THE PATIENT AND WAS DISCARDED. A NEW DEVICE WAS OPENED AND WAS DELIVERED SUCCESSFULLY. THERE WERE NO INJURIES TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290897 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04197253

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR