BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 4785927 · Received May 20, 2015

    Report

    Report Number
    2953200-2015-00920
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THORACIC DEVICE USED FOR AAA.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61.7MM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK DIAMETER WAS 42.5MM AND 22.5MM IN LENGTH. THE DISTAL NECK DIAMETER WAS 38MM. DURING DEPLOYMENT OF THE STENT GRAFT JUST BELOW THE INTENDED TARGET OF THE LEFT RENAL ARTERY THE PHYSICIAN HAD THE IMAGE INTENSIFIER IN A CRANIAL 20DEGREE ANGULATION. DUE TO THE PATIENT'S SPINAL HARDWARE IMPLANTS, VISUALIZATION OF THE RENAL ARTERIES WAS DIFFICULT. THE PHYSICIAN MOVED THE IMAGE INTENSIFIER TO AN ANGULATION OF LAO 20 DEGREES AND REPEATED THE ANGIOGRAM THEREBY VISUALIZING THE RENAL ARTERIES BETTER. UPON ADJUSTMENT TO A PROJECTION OF LAO 20DEGREES, THE PHYSICIAN NOTICED THE PROXIMAL MARKERS OF THE 46X46X100 WERE NOT ALIGNED AND FURTHER ADJUSTED THE IMAGE INTENSIFIER TO LAO 20DEGREES/CAUDAL 10DEGREES. IT WAS IN THIS POSITION THAT THE PHYSICIAN COMPLETED THE FULL DEPLOYMENT OF THE STENT GRAFT. UPON FINAL ANGIOGRAM IT WAS REVEALED THAT THE LEFT RENAL ARTERY WAS COVERED BY THE STENT GRAFT. NO ADDITIONAL TREATMENT WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. REVIEW OF A PRE-IMPLANT PLANNING 3D REPORT CONFIRMED THAT NECK DIAMETER JUST BELOW THE RENALS WAS 42.5MM, AND 22MM BELOW MEASURED 38 X40MM. THE NECK WAS MILDLY ANGULATED WITH MINIMAL CALCIFICATION. THE MAX AAA MEASURED 62MM, AND THE LENGTH FROM THE RENALS TO THE AORTIC BIFURCATION WAS 145MM. THE DISTAL AORTIC DIAMETER WAS 32MM AND CALCIFIED. THE ILIACS WERE MODERATELY TORTUOUS. IMAGES DURING IMPLANT WERE NOT AVAILABLE FOR REVIEW. THE CAUSE OF THE INACCURATE DELIVERY COULD NOT BE DETERMINED FROM THE IMAGES PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327286 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04671580

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR