BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 13257963 · Received January 14, 2022

    Report

    Report Number
    9612164-2022-00222
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    November 1, 2021
    Report Date
    January 14, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED;SAFETY AND DURABILITY OF SINGLE-STAGE TYPE I HYBRID TOTAL AORTIC ARCH REPAIR FOR EXTENSIVE AORTIC ARCH DISEASE: EARLY- AND LONG-TERM CLINICAL OUTCOMES FROM A SINGLE CENTER AND OUR 10-YEAR OF EXPERIENCE ZHANG B, WEI Y, LIU Y, LIN H, LIANG S, DUN Y, YU C, QIAN X, GUO H, SUN X JOURNAL OF THORACIC DISEASE 2021;13(11):6230-6239 HTTP://DX.DOI.ORG/10.21037/JTD-20-3479. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT , VALIANT CAPTIVIA STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF SINGLE-STAGE TYPE I HYBRID TOTAL AORTIC ARCH REPAIR. TYPE I HYBRID TOTAL AORTIC ARCH REPAIR WAS DEFINED AS SURGICAL TOTAL SUPRA-ARCH DEBRANCHING AND ZONE 0 STENT GRAFT DEPLOYMENT TO EXCLUDE THE ENTIRE DISEASED AORTIC ARCH. THE PATIENTS EXPERIENCED VARIOUS AORTIC PATHOLOGIES INCLUDING ANEURYSMS, DISSECTIONS AND AORTIC ULCERS. THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED; STROKE, INFECTION, DISSECTION, RESPIRATORY FAILURE, RE-INTERVENTION, MULTI-ORGAN FAILURE , RENAL FAILURE, PNEUMONIA, FALSE LUMEN ENLARGEMENT PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681988 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other| R