BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3884930 · Received June 19, 2014

    Report

    Report Number
    2953200-2014-01234
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 73MM FUSIFORM (ZONE 4) THORACIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK DIAMETER OF SG SEAL ZONE IS 30.2X32.6MM AND DISTAL DIAMETER OF PROXIMAL NECK IS 30.8X33MM. PROXIMAL DIAMETER OF DISTAL NECK IS 40.7X44.3MM. DIAMETER PROXIMAL TO THE CELIAC ARTERY IS 40.8X40MM. PROXIMAL NECK LENGTH BY CENTERLINE IS 30MM. DURING THE INDEX PROCEDURE THE FIRST VALIANT STENT GRAFT WAS IMPLANTED AT THE PROXIMAL SIDE WITHOUT ISSUES. THEN THE SECOND VALIANT STENT GRAFT WAS IMPLANTED AND TOUCH-UP WAS CARRIED OUT WITH ANOTHER MANUFACTURER¿S BALLOON CATHETER. THE PHYSICIAN INFLATED THE BALLOON WITH IN IFU INSTRUCTIONS IN THE STENT GRAFT FABRIC. ANGIOGRAPHY CONFIRMED A DISSECTION ORIGINATING FROM THE GREATER CURVATURE SITE WHERE THE FIRST VALIANT STENT GRAFT WAS IMPLANTED. THE PHYSICIAN DECIDED TO TREAT THE DISSECTION BY ADDING ANOTHER MANUFACTURER¿S STENT GRAFT AND THE TYPE A DISSECTION WAS RESOLVED. NO LEAKS WERE IDENTIFIED AT THE END OF THE PROCEDURE. THE PHYSICIAN NOTED THE CAUSE OF THE DISSECTION DUE TO THE GREATER CURVATURE OF THE CALCIFIED SITE AND THE TIP OF THE BARE STENT CAUSED THE DISSECTION WHILE TOUCH UP WAS APPLIED DURING THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360115 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01706774

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention