BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 11648127 · Received April 12, 2021

    Report

    Report Number
    9612164-2021-01413
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    October 25, 2020
    Report Date
    April 12, 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; ONE-STAGE HYBRID PROCEDURE FOR DISTAL AORTIC ARCH DISEASE: MID-TERM EXPERIENCE AT A SINGLE CENTER CHEN SW, ZHONG YL, QIAO ZY, LI CN, GE YP, QI RD, HU HO, SUN LZ, ZHU JM. JOURNAL OF THORACIC DISEASE 2020;12(12):7117-7126. DOI:10.21037/JTD-20-2338. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFTS AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN ONE-STAGE HYBRID PROCEDURES COMBINING THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WITH EXTRA-ANATOMIC BYPASS FOR THE TREATMENTS OF DISTAL AORTIC ARCH DISEASE ON UNKNOWN DATES. THE FOLLOWING MALFUNCTIONS WERE REPORTED; MIGRATION, TYPE I ENDOLEAK, TYPE II ENDOLEAK. THE FOLLOWING ADVERSE EVENTS WERE REPORTED; STROKE, THROMBOSIS/STENOSIS, INFECTION, SPINAL CORD INJURY, RUPTURE, D-SINE, BLEEDING, RE-INTERVENTION. PATIENT DEATHS WERE REPORTED BUT THERE IS NO CAUSAL LINK THAT A VALIANT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547789 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR