BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK-CV-SR

    MDR report key: 13332439 · Received January 24, 2022

    Report

    Report Number
    9612164-2022-00294
    Event Type
    Death
    Date Received
    January 24, 2022
    Date of Event
    July 26, 2021
    Report Date
    January 24, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED;THE FATE OF THE LEFT SUBCLAVIAN ARTERY IN TEVAR FOR AORTIC ARCH PATHOLOGY BASHIR ET AL, JOURNAL OF CARDIAC SURGERY 2021;36:3547-3553 DOI: 10.1111/JOCS.15831.IMPLANT DATE: EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    AN UNKNOWN MEDTRONIC THORACIC ENDOGRAFT WAS IMPLANTED IN PATIENTS DURING THE ENDOVASCULAR TREATMENT OF TAAA AND TBAD ON UNKNOWN DATES. IN SOME PATIENTS THE ORIGIN OF THE LSA WAS OCCLUDED AND/OR EXTRA-ANATOMICAL BYPASS WAS COMPLETED. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: PATIENT DEATHS. THE CAUSE OF THE DEATHS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671940 UNK-CV-SR SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| D