BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 10269612 · Received July 14, 2020

    Report

    Report Number
    9612164-2020-02570
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    January 11, 2020
    Report Date
    August 7, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT OF THE ADVERSE EVENTS REPORTED IN THE JOURNAL ARTICLE, NONE WERE DIRECTLY LINKED TO A MDT DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; MID-TERM RESULTS OF IN SITU FENESTRATION STENTED WITH BALLOON EXPANDABLE BARE METAL STENTS DURING THORACIC ENDOVASCULAR AORTIC REPAIR. BAI J, LIU Y, JIN J, WU J, QU L. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2020;95:1163¿1168. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFT AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR VARIOUS THORACIC PATHOLOGIES (ANEURYSMS, DISSECTIONS AND THORACIC PENETRATING ULCERS) IN TEVAR PROCEDURES COMBINED WITH IN SITU FENESTRATION (ISF), ALONG WITH THE IMPLANTATION OF BARE METAL STENTS. THE FOLLOWING MALFUNCTIONS WERE OBSERVED; TYPE IIIA ENDOLEAKS (AT THE CONNECTING SITE OF THE BRIDGE BARE METAL STENT AND AORTIC STENT GRAFT). THE FOLLOWING ADVERSE EVENTS WERE REPORTED; THROMBOSIS, HEMATOMA, DISSECTION, OCCLUSION AND RE-INTERVENTION. THERE WAS NO PATIENT MORTALITY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733498 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R