BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 13168533 · Received January 5, 2022

    Report

    Report Number
    9612164-2022-00049
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    January 25, 2021
    Report Date
    January 5, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR IN SITU FENESTRATION TECHNIQUE OF AORTIC ARCH PATHOLOGY: A SYSTEMATIC REVIEW AND META-ANALYSIS LI ET AL, ANN VASC SURG 2021; 76: 472¿480 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.12.021 THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH. DEATHS ARE COMMON OCCURRENCES HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE AS MDR OR VIGILANCE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH MEDTRONIC PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    VALIANT AND TALENT STENT GRAFTS WERE IMPLANTED IN CONJUNCTION WITH NON MDT STENT GRAFTS DURING THE ENDOVASCULAR TREATMENT OF THORACIC ANEURYSMS, THORACIC DISSECTIONS, INTRAMURAL HEMATOMAS AND PENETRATING ULCERS USING AN IN SITU FENESTRATION (ISF) TECHNIQUE ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: STROKE, DISSECTION, LEFT BRACHIAL ARTERY HEMATOMA, PARAPLEGIA, LSA STENOSIS, ACCESS RELATED COMPLICATION, RENAL FAILURE, AORTO-OESOPHAGEAL FISTULA PNEUMONIA, INTERVENTION AND DEATH. THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348643 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention