BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT

    MDR report key: 4243460 · Received November 11, 2014

    Report

    Report Number
    2953200-2014-02377
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT WAS INSERTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN EMERGENT AORTIC TRANSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN ATTEMPTED TO PASS THE DELIVERY SYSTEM ON THE RIGHT AND THEN ON THE LEFT SIDE; HOWEVER, THE 24 FRENCH DEVICE PROVED TO BE TOO BIG FOR THE PATIENT¿S ANATOMY. IN ADDITION, THE PHYSICIAN NOTED THAT THERE WAS A GAP BETWEEN THE DILATOR (NOSE CONE) AND THE GRAFT COVER AFTER REMOVING THE DEVICE FROM THE PATIENT. THE PHYSICIAN TRIED TO CLOSE THE GAP WITH MANUAL PRESSURE; HOWEVER, WAS NOT SUCCESSFUL. THE PHYSICIAN DECIDED TO USE A 32X70MM LONG ENDURANT CUFF AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURIES TO THE PATIENT. THE PHYSICIAN NOTED THAT THE GAP BETWEEN THE NOSE CONE AND THE GRAFT COVER ATTRIBUTED THE EVENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. THE DEVICE WAS RETURNED WITHIN ITS ORIGINAL PACKAGING, INSIDE AN ENDOVASCULAR RETURN KIT. THE CATALOG AND LOT NUMBERS ON THE LABEL MATCHED THE NUMBER FROM THE EVENT. THE DEVICE WAS RETURNED WITH NO SIGNS OF BLOOD AND WITH THE STENT GRAFT LOADED WITHIN THE DELIVERY SYSTEM. UPON INSPECTION OF THE DEVICE, THERE WAS A 1 MM GAP BETWEEN THE GRAFT COVER AND TAPERED TIP, WHICH IS WITHIN MANUFACTURING SPECIFICATION. THE REST OF THE DEVICE WAS UNREMARKABLE. THE EVENT WAS CONFIRMED; THERE WAS SMALL GAP BETWEEN THE GRAFT COVER AND TAPERED TIP. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE GAP WAS WITHIN MANUFACTURING SPECIFICATION. IN ADDITION, INSERTION AND REMOVAL OF THE DEVICE FROM THE PATIENT MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726320 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04106215

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR