BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 12268110 · Received August 3, 2021

    Report

    Report Number
    9612164-2021-02981
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    September 3, 2020
    Report Date
    August 3, 2021
    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 FROM A JOURNAL ARTICLE ENTITLED;ENDOVASCULAR TREATMENT OF SPONTANEOUS AND ISOLATED INFRARENAL ACUTE AORTIC SYNDROME WITH UNIBODY AORTIC STENT-GRAFTS PECORARO F, DINOTO E, MIRABELLA D, FERLITO F, FARINA A, PAKELIANI D, LACHAT M, URSO F, BAJARDI G. WORLD JOURNAL OF SURGERY (2020) 44:4267¿4274 HTTPS://DOI.ORG/10.1007/S00268-020-05754-1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NON MDT UNIBODY STENT-GRAFTS WERE IMPLANTED IN 21 PATIENTS IN THE ENDOVASCULAR TREATMENT OF SPONTANEOUS ACUTE AORTIC SYNDROMES. 2 PATIENTS HAD PROXIMAL ENDURANT STENT GRAFTS EXTENSIONS IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE REPORTED; COMMON FEMORAL ARTERY OCCLUSION ON 2ND POST-OPERATIVE DAY 1 PATIENT DEATH WAS REPORTED DUE TO A NON AORTIC RELATED REASON AT 21 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164075 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 71 YR Other