BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 10559301 · Received September 21, 2020

    Report

    Report Number
    9612164-2020-03527
    Event Type
    Death
    Date Received
    September 21, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 21, 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: BELL-BOTTOM TECHNIQUE IN ILIAC BRANCH ERA: MID-TERM SINGLE STENT GRAFT PERFORMANCE. PAGLIARICCIO, G., GATTA, E., SCHIAVON, S. ET AL. BELL-BOTTOM TECHNIQUE IN ILIAC BRANCH ERA: MID-TERM SINGLE STENT GRAFT PERFORMANCE. CVIR ENDOVASC 3, 57 (2020). HTTPS://DOI.ORG/10.1186/S42155-020-00147-W AVERAGE PATIENT AGE MEAN GENDER. 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 RECEIVING STANDARD EVAR COMBINED WITH BELLBOTTOM TECHNIQUE (BBT). THE FOLLOWING ADVERSE EVENTS WERE REPORTED: AT 5 YEARS, THE NUMBER OF ALL-CAUSE DEATHS WAS SEVEN. 5-YEAR ARM WAS NOT FOUND, HOWEVER ONE PATIENT DIED FROM MULTI ORGAN FAILURE AFTER REINTERVENTION FOR A TYPE IB ENDOLEAK ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028131 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death