BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 13690280 · Received March 8, 2022

    Report

    Report Number
    2029214-2022-00368
    Event Type
    Death
    Date Received
    March 8, 2022
    Date of Event
    March 1, 2019
    Report Date
    March 7, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEPARATE REPORT WAS SUBMITTED FOR PATIENT INJURIES REPORTED IN THIS ARTICLE WITH RR #: 2029214-2022-00367. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CORLISS, B. M., BARKLEY, K. F., POLIFKA, A. J., HOH, B. L., FOX, W. C. (2019). SINGLE-CENTER CASE SERIES OF TEMPORARY STENT ASSISTANCE FOR COILING OF ACUTELY RUPTURED ANEURYSMS. WORLD NEUROSURGERY, 123, E766¿E772. HTTPS://DOI.ORG/10.1016/J.WNEU.2018.12.029 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A REVIEW OF 7 CASES IN WHICH PATIENTS UNDERWENT PROCEDURES TO TREAT WIDE-NECKED INTRACRANIAL ANEURYSMS. IN SIX OF THE SEVEN CASES THE SOLITAIRE FR STENT RETRIEVER WAS USED IN STENT ASSISTED COIL EMBOLIZATION FOR PATIENTS WHO HAD RUPTURED ANEURYSMS TO AVOID USE OF HEPARIN DUR TO THE PREEXISTING . THERE WAS NO DEVICE MALFUNCTIONS NOTED WITH ANY OF THE SOLITAIRE DEVICES USED. IT WAS NOTED THAT ONE PATIENT DIED DURING THE FOLLOW-UP PERIOD; CAUSE OF DEATH WAS NOT REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655637 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SFR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death