BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10446951 · Received August 25, 2020

    Report

    Report Number
    9612164-2020-03111
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    February 19, 2020
    Report Date
    November 2, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COST-EFFECTIVENESS ANALYSIS OF CHIMNEY/SNORKEL VERSUS FENESTRATED ENDOVASCULAR REPAIR FOR HIGH-RISK PATIENTS WITH COMPLEX ABDOMINAL AORTIC PATHOLOGIES TANEVA ET AL, J CARDIOVASC SURG 2020;61:18-23. DOI: 10.23736/S0021-9509.19.11146-9. IMPLANT DATE: EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR TREATMENT OF COMPLEX ABDOMINAL AORTIC PATHOLOGIES ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE I ENDOLEAKS, MIGRATION AND AN UPPER EXTREMITY SHEATH BECAME TRAPPED BY THE AORTIC STENT GRAFT PINS. THE CAUSE OF THE EVENTS ARE UNDERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914540 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1