BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10218310 · Received July 1, 2020

    Report

    Report Number
    9612164-2020-02383
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    February 11, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: THERAPEUTIC MANAGEMENT OF ISOLATED INTERNAL ILIAC ARTERY ANEURYSMS. MENG Y, LECONG L, YANG L, QINGBO S, ZHAORU D, GUANGZHEN L, JIANJUN J & XIANGJIU D. JOURNAL OF VASCULAR SURGERY 2020 (20) 30463-8. DOI: 10.1016/J.JVS.2020.02.038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT ILIAC LIMBS STENT GRAFTS WERE IMPLANTED ALONE OR IN COMBINATION WITH A COIL EMBOLIZATION PROCEDURE IN THE ENDOVASCULAR TREATMENT OF ISOLATED INTERNAL ILIAC ARTERY ANEURYSMS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED: UNKNOWN ENDOLEAK TYPE IB ENDOLEAK (RETROGRADE FILLING OF DISTAL BRANCHES). THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: CLAUDICATION ANEURYSM ENLARGEMENT ACUTE ISCHEMIC STROKE RE-INTERVENTION ANEURYSM RUPTURE HYDRONEPHROSIS PATIENT DEATHS WERE ALSO REPORTED, BUT THERE IS NO CAUSAL LINK THAT THE MDT DEVICE CAUSED OR CONTRIBUTED TO THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684698 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR