BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10447441 · Received August 25, 2020

    Report

    Report Number
    9612164-2020-03131
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    December 20, 2019
    Report Date
    August 25, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: ANALYSING THE SOCIETY FOR VASCULAR SURGERY AND AMERICAN ASSOCIATION FOR VASCULAR SURGERY SCORING SYSTEMS FOR OUTCOMES POST-ENDOVASCULAR AORTIC REPAIR CANNING ET AL, IR J MED SCI 189, 1005¿1013 (2020). HTTPS://DOI.ORG/10.1007/S11845-019-02160-Y. EXACT DATE OF IMPLANT UNKNOWN. THE CAUSE OF THE PATIENT DEATHS WERE UNDETERMINED WITH NO CAUSAL LINK THAT THE ENDURANT STENT GRAFTS CAUSED OR CONTRIBUTED TO THESE DEATHS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: ADMISSION TO HDU AND ICU POST THE INDEX PROCEDURE FOR GREATER THAN 5 DAYS. THE CAUSE OF PROLONGED HOSPITALIZATION HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912097 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization