BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 8845917 · Received July 31, 2019

    Report

    Report Number
    9612164-2019-03148
    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
    P070027
    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
    639412 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention