BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 13288390 · Received January 19, 2022

    Report

    Report Number
    9612164-2022-00264
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    September 4, 2021
    Report Date
    January 19, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; SEQUENTIAL MINIMALLY INVASIVE TREATMENT OF CONCOMITANT ABDOMINAL AORTIC ANEURYSM AND COLORECTAL CANCER: A SINGLE-CENTER EXPERIENCE UMBERTO BRACALE U, DI NUZZO M, MARCELLO BRACALE U, DEL GUERCIO L, PANAGROSSO M, SERRA R, TERRACCIANO R M, DE WERRA C, CORCIONE F, PELTRINI R, AND SODO M ANNALS OF VASCULAR SURGERY 2022; 78: 226¿232 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.07.009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    24 PATIENTS UNDERWENT EVAR PROCEDURES FOR ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE MEAN DIAMETER THE AAA'S WAS 6.6CM. THESE PATIENTS ALL HAD DIAGNOSIS OF COLORECTAL CANCER WERE CONSECUTIVELY TREATED BY EVAR AND LAPAROSCOPIC COLORECTAL RESECTION. BOTH ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED. THE FOLLOWING MALFUNCTION WAS REPORTED TYPE IB ENDOLEAK (2 MONTHS POST EVAR) PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS. CAUSES OF DEATH WERE CANCER AND CARDIOVASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052511 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male