BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 14071084 · Received April 11, 2022

    Report

    Report Number
    9612164-2022-01384
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    October 20, 2021
    Report Date
    April 11, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; CHANGES IN ANESTHESIA CAN REDUCE PERIPROCEDURAL URINARY RETENTION AFTER EVAR GUERRA A, CHAO C, WALLACE G, RODRIQUEZ H, ESKANDARI M ANN VASC SURG 2022; 79: 91¿99. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.08.033. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES BETWEEN OVER A 3 YEAR PERIOD. THE FOLLOWING ADVERSE EVENTS WERE REPORTED; HEMATOMAS, URINARY RETENTION, UTI REQUIRING INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488826 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention