BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 13690003 · Received March 8, 2022

    Report

    Report Number
    2029214-2022-00367
    Event Type
    Injury
    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 WILL BE SUBMITTED FOR THE SINGLE PATIENT DEATH REPORTED IN THIS ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    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. TWO PATIENTS EXPERIENCED RADIOGRAPHIC THROMBOEMBOLIC COMPLICATIONS: ONE HAD ANGIOGRAPHIC EVIDENCE OF ISCHEMIA AND THE OTHER HAD ANGIOGRAPHIC EVIDENCE OF VESSEL THROMBOSIS. ONE OF THESE PATIENTS SUCCESSFUL THROMBECTOMY DURING THE INDEX PROCEDURE WITH THE SAME SOLITAIRE DEVICE USED FOR STENT ASSISTED COILING. NEITHER PATIENT EXPERIENCED ANY RELATED NEUROLOGIC DEFICITS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654580 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SFR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention