BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 12759938 · Received November 7, 2021

    Report

    Report Number
    9612164-2021-04262
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    February 4, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ALFAWAZ ET AL, ANN VASC SURG 2021; 74: 237¿245. HTTPS://DOI.ORG/10.1016/J.AVSG.2020.12.043. EXACT DATE OF IMPLANT UNKNOWN. THERE WERE 6 PERIOPERATIVE DEATHS HOWEVER THERE WAS NO INFORMATION TO SUGGEST ANY OF MEDTRONIC DEVICE FAILURES CAUSED OR CONTRIBUTED TO THE DEATHS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AAA ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: REINTERVENTION, LOWER EXTREMITY WEAKNESS, RENAL FAILURE,OCCLUSION AND ISCHEMIA. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660021 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| R