BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10592685 · Received September 28, 2020

    Report

    Report Number
    9612164-2020-03655
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    March 20, 2020
    Report Date
    September 28, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: PARTIAL ENDOGRAFT REMOVAL PRESERVES THE AORTIC WALLS DURING DELAYED OPEN CONVERSIONS OF ENDOVASCULAR AORTIC REPAIR MARONE ET AL, ANN VASC SURG 2020; 67: 546¿552 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.02.024. EXACT DATE OF IMPLANT UNKNOWN. 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 DURING UNKNOWN EVAR PROCEDURES ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: NOSOCOMIAL PNEUMONIA AND OPEN CONVERSION WITH PARTIAL ENDOGRAFT REMOVAL. THE CAUSE OF THE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057614 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention