BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 11145518 · Received January 11, 2021

    Report

    Report Number
    9612164-2021-00101
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    May 1, 2020
    Report Date
    January 11, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; THE SURGICAL MANAGEMENT OF RETROGRADE TYPE A AORTIC DISSECTION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR DUN Y, SHI Y, GUO H, LIU Y, ZHANG B, SUN X, QIAN X, YU C INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 30 (2020) 732¿738 DOI:10.1093/ICVTS/IVZ326. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TALENT & VALIANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF VARIOUS THORACIC PATHOLOGIES. ALL PATIENTS HAD RETROGRADE TYPE A DISSECTIONS (RTAD) DIAGNOSED FOLLOWING TEVAR WHICH WERE SURGICALLY MANAGED. THE MEDIAN INTERVAL BETWEEN THE TEVAR PROCEDURE AND THE RTAD WAS 4.6 MONTHS. SURGICAL TREATMENTS FOR THE DISSECTIONS INCLUDED TOTAL ARCH REPLACEMENT, SOME USING THE FROZEN ELEPHANT TRUNK TECHNIQUE. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE IA ENDOLEAK FOLLOWING THIS THE FOLLOWING ADVERSE EVENTS WERE OBSERVED; STOKE, MYOCARDIAL INFRACTION, RENAL FAILURE, BLEEDING PATIENT DEATHS WERE ALSO REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO THESE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44529 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR