BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10585120 · Received September 25, 2020

    Report

    Report Number
    9612164-2020-03613
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    April 10, 2020
    Report Date
    September 25, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; LONG-TERM EFFICACY OF EVAR IN PATIENTS AGED LESS THAN 65 YEARS WITH AN INFRARENAL ABDOMINAL AORTIC ANEURYSM AND FAVORABLE ANATOMY GALLITTO E, FAGGIOLI G, MASCOLI C, SPATH P, PINIR, RICCO J B, LOGIACCO A, SONETTO A, & GARGIULO M ANNALS OF VASCULAR SURGERY 2020; 67: 283¿292 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.03.038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, TYPE II ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; THROMBOSIS, BLEEDING, SAC ENLARGEMENT, OCCLUSION, FEMORAL WOUND DEHISCENCE & RE- INTERVENTION PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL EVIDENCE THAT THE ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO THESE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050981 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR