BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3882235 · Received June 18, 2014

    Report

    Report Number
    2953200-2014-01221
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 6, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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 FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM . VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A TEVAR AS PART OF AN INITIAL TREATMENT PLAN THAT INCLUDED A TOTAL ARCH REPLACEMENT AND ELEPHANT TRUNK PROCEDURE 10 DAYS PREVIOUSLY. THE LEFT SUBCLAVIAN ARTERY AND CAROTID ARTERY WERE CLOSE TOGETHER, WHICH MADE IT DIFFICULT FOR THE PHYSICIAN TO MEASURE THE DISTANCE BETWEEN THE TWO. THE VALIANT STENT GRAFT WAS IMPLANTED, AND THE LEFT SUBCLAVIAN ARTERY WAS PARTIALLY OCCLUDED. DURING THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE COULD NOT BE CONTROLLED, AND AS A RESULT, THE PHYSICIAN DEPLOYED THE DEVICE SLIGHTLY PROXIMAL TO THE INTENDED LOCATION TO TAKE INTO ACCOUNT THE POSSIBILITY OF DEVICE MIGRATION DUE TO BLOOD FLOW. ONE WEEK AFTER THE PROCEDURE, THE PATIENT WAS REPORTED TO BE SUFFERING FROM PARAPARESIS. THE PHYSICIAN STATES THE CAUSE WAS LIKELY DUE TO OCCLUSION OF THE ADAMKIEWICZ ARTERY. THE AORTIC ARCH WAS REPLACED BY ANOTHER MANUFACTURER'S DEVICE, AS THE AORTA WAS REPORTED TO BE OF UNUSUAL SHAPE, (SQUARISH), AND THE VALIANT REMAINS IMPLANTED. THE PATIENT HAS NOT RECOVERED. THE PHYSICIAN COMMENTED THAT ONE WEEK AFTER TEVAR, IT WAS CONFIRMED THAT THE PATIENT HAD PARAPARESIS. IT WOULD HAVE OCCURRED BY OCCLUSION OF THE ADAMKIEWICZ ARTERY. SPINAL DRAINAGE WAS CARRIED OUT FOR THE PATIENT.

    Description of Event or Problem · 1

    A REVIEW OF RETURNED FILMS WAS PERFORMED. CTA IMAGES PRE-IMPLANT REVEALED A THORACIC AORTIC ANEURYSM IN THE AORTIC ARCH THAT MEASURED APPROXIMATELY 5.4CM MAXIMUM DIAMETER. AT THE THORACIC AORTIC MAXIMUM DIAMETER, THERE APPEARED TO BE A PARTIAL DISSECTION OR A PSEUDOANEURYSM. JUST DISTAL TO THE TAA, IN THE STRAIGHT SECTION OF THE DESCENDING THORACIC, THE AORTIC DIAMETER FLOW LUMEN MEASURED 29 X 30MM. NUMEROUS VESSELS WERE SEEN COMING OFF THE DESCENDING THORACIC AS IT COURSED DISTALLY. JUST PROXIMAL TO THE CELIAC ARTERY THE AORTIC DIAMETER FLOW LUMEN MEASURED 24MM. THE PATIENT ALSO HAD A AAA WHICH MEASURED APPROXIMATELY 3CM. IMAGES AFTER THE ARCH REPLACEMENT AND DURING THE IMPLANT PROCEDURE WERE NOT AVAILABLE FOR REVIEW, AND IMAGES POST-IMPLANT WERE NOT PROVIDED. THE LOCATION OF THE REPORTED ADAMKIEWICZ ARTERY (WHICH REPORTEDLY OCCLUDED POST-IMPLANT) COULD NOT BE IDENTIFIED, AND THE CAUSE OF THE PARAPARESIS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358847 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention