BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 12416147 · Received September 2, 2021

    Report

    Report Number
    9612164-2021-03408
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    April 2, 2021
    Report Date
    September 2, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED NOTIFICATION OF A LITERATURE ARTICLE ENTITLED: "CLINICAL COMPARISON BETWEEN EARLY AND LATE SPONTANEOUS SAC SHRINKAGE AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR" MASAYUKI SUGIMOTO, HIROSHI BANNO, TOMOHIRO SATO, SHUUTA IKEDA, TAKUYA TSURUOKA, YOHEI KAWAI, KIYOAKI NIIMI, AKIO KODAMA, AND KIMIHIRO KOMORI ANN VASC SURG 2021; 75: 420¿429 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.02.014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT TALENT STENT GRAFTS WERE IMPLANTED IN PATIENTS ALONG WITH NON MEDTRONIC STENT GRAFTS FOR AN EVAR ENDOVASCULAR TREATMENT. ABSTRACT: EARLY SPONTANEOUS SHRINKAGE (ESS) OF ABDOMINAL AORTIC ANEURYSM (AAA) WITHIN 1 YEAR AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) COULD BE A PREDICTOR OF DURABLE SUCCESS. HOWEVER, LATE SPONTANEOUS SHRINKAGE (LSS) DURING LONGER FOLLOW-UP HAS NOT BEEN WELL ADDRESSED. WE COMPARED LATE COMPLICATIONS OF ESS AND LSS. THE FOLLOWING MALFUNCTION WERE REPORTED; TYPE IA, IB, II & TYPE III ENDOLEAKS THE FOLLOWING SERIOUS INJURIES WERE REPORTED: BYPASS SURGERY, OCCLUSION, ILIAC ACCESS SITE INJURY, ANEURYSM EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313570 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR