BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7685459 · Received July 13, 2018

    Report

    Report Number
    2953200-2018-01018
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; OPEN THORACIC AND THORACO-ABDOMINAL AORTIC REPAIR AFTER PRIOR ENDOVASCULAR THERAPY PAULA R. KESCHENAU, SHIRLEY KETTING, BAREND MEES, MOHAMMAD E. BARBATI, JOCHEN GROMMES, ALEXANDER GOMBERT, GEERT WILLEM H. SCHURINK, DROSOS KOTELIS, MICHAEL J. JACOBS EUR J VASC ENDOVASC SURG (2018) 56, 57-67, DOI.ORG/10.1016/J.EJVS.2018.03.015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA STENT GRAFT SYSTEMS WERE IMPLANTED INTO PATIENTS FOR EVAR, TEVAR AND FEVAR TREATMENTS ON UNKNOWN DATES. THE LIST OF EVENTS THAT OCCURRED ARE THE FOLLOWING; SERIOUS INJURY; INFECTION, INTRA OPERATIVE ANEURYSM RUPTURE, SEPSIS, HEMORRHAGIC CEREBELLAR INFARCTION, MESENTERIC ISCHEMIA, FISTULAS, MULTI-ORGAN FAILURE, HAEMORRHAGE, PNEUMONIA, DIALYSIS, POST-OPERATIVE RENAL FAILURE, PARAPARESIS, STROKE, EXPLANTATION, POST DISSECTION ANEURYSM, DISSECTIONS TYPE A AND B, BYPASS, PERITONITIS, WOUND HEALING ISSUES AT SURGICAL SITE, POST OPERATIVE EMPYEMA, ENDOCARDITIS, OCCLUSION, ABSCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530210 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| S