BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 3803082 · Received May 9, 2014

    Report

    Report Number
    2953200-2014-00964
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 21, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE - (IMPLANTING THE DEVICE IN ZONE 1).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A CHRONIC DISSECTION IN THE THORACIC AORTA. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL START OF THE FALSE LUMEN WAS IN ZONE 3. THE DIAMETER OF THE PROXIMAL AORTIC NECK WAS 23 MM AND THE LENGTH WAS 18 MM. A REVASCULARIZATION OF BRACHIOCEPHALIC TRUNK WAS PERFORMED PRIOR TO ON THE SAME DAY AS THE INDEX PROCEDURE. THE LSA WAS INTENTIONALLY COVERED AND THE STENT GRAFT WAS IMPLANTED IN ZONE 1. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED WITHOUT ISSUE. IT WAS REPORTED THAT FOLLOWING DAY, THE PATIENT EXPERIENCED A CVA/STROKE. THE INVESTIGATOR INDICATED THAT THE CVA/STROKE WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS TREATED WITH MEDICATION AND THE CVA/STROKE WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281604 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04162989

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention