BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13225348 · Received January 11, 2022

    Report

    Report Number
    9612164-2022-00149
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    August 30, 2021
    Report Date
    January 11, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; APPLICATION OF THE ANGIOJET ULTRA THROMBECTOMY DEVICE FOR THE PERCUTANEOUS MECHANICAL TREATMENT (PMT) OF ILIAC LIMB OCCLUSION AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) XIAOFENG HAN, GUANGRUI LIU, TIEZHENG LI, AND XI GUO, ANN VASC SURG 2022; 78: 161¿169 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.06.016. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT STENT GRAFTS WERE IMPLANTED IN PATIENTS DURING THE ENDOVASCULAR TREATMENT OF INFRARENAL ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: STENT ANGULATION/STENT THROMBOSIS, ILIAC LIMB OCCLUSION, REINTERVENTION/THROMBECTOMY, IN TERMITTENT CLAUDICATION/BUTTOCK CLAUDICATION, GROSS HEMATURIA AND RENAL DYSFUNCTION POST INTERVENTION. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094581 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention