BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 10400520 · Received August 13, 2020

    Report

    Report Number
    9612164-2020-02977
    Event Type
    Death
    Date Received
    August 13, 2020
    Date of Event
    March 16, 2020
    Report Date
    August 13, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; FIVE-YEAR OUTCOMES OF ENDOVASCULAR REPAIR OF COMPLICATED ACUTE TYPE B AORTIC DISSECTIONS. BAVARIA E J, MD, BRINKMAN T W, HUGHES C G, SHAH S A, CHARLTON-OUW M K, , AZIZZADEH A & WHITE A R. THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 2020;S0022-5223(20)31092-8. DOI: HTTPS://DOI.ORG/10.1016/J.JTCVS.2020.03.162. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN 50 PATIENTS FOR THE ENDOVASCULAR REPAIR OF ACUTE TYPE B THORACIC AORTIC DISSECTIONS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE IA ENDOLEAK, TYPE II ENDOLEAK, UNKNOWN ENDOLEAK, FALSE LUMEN PERFUSION. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; OCCLUSION, DISSECTIONS, CVA, PARALYSIS, PARAPLEGIA, INFECTION, ISCHEMIA, HEMORRHAGE, CLAUDICATION, ACUTE RENAL FAILURE, RESPIRATORY FAILURE, PULMONARY EMBOLISM, , EMBOLISM, ANEURYSM ENLARGEMENT, THROMBOSIS, CARDIAC ARREST, RE-INTERVENTION PATIENT DEATHS WERE REPORTED; DISSECTION RELATED DEATHS > 1 YEAR POST INDEX PROCEDURE, PROCEDURE RELATED DEATHS WITHIN 30 DAYS OF INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869042 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death