BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 8846094 · Received July 31, 2019

    Report

    Report Number
    9612164-2019-03154
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 28, 2017
    Report Date
    July 31, 2019
    Manufacturer
    MEDTRONIC IRELAND
    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

    PATIENT DEATHS WERE ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICES USED IN THE PATIENT COHORT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS WAS PROVIDED. JOURNAL ARTICLE DETAILS; TITLE: RENAL DYSFUNCTION AFTER ABDOMINAL OR THORACIC ENDOVASCULAR AORTIC ANEURYSM REPAIR: INCIDENCE AND RISK FACTORS AUTHORS: SHUJI IKEDA, MAKIYO HAGIHARA, AKIRA KITAGAWA, YUICHIRO IZUMI, KOJIRO SUZUKI, TOYOHIRO OTA, TSUNEO ISHIGUCHI, HIROYUKI ISHIBASHI. JPN J RADIOL (2017). 35: 562¿567, DOI: 10.1007/S11604-017-0666-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TALENT AAA AND ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT GROUP FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. TALENT TAA AND VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A SECOND PATIENT GROUP FOR ENDOVASCULAR THORACIC AORTIC ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED IN BOTH PATIENT GROUPS: RENAL DYSFUNCTION RENAL ARTERY OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639028 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention