BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 12391898 · Received August 31, 2021

    Report

    Report Number
    2029214-2021-01091
    Event Type
    Death
    Date Received
    August 31, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 31, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BAEK J-H, JUNG C, KIM BM, HEO JH, KIM DJ, NAM HS, KIM YD, LIM EH, KIM J-H, KIM JY AND KIM JH (2021) COMBINATION OF RESCUE STENTING AND ANTIPLATELET INFUSION IMPROVED OUTCOMES FOR ACUTE INTRACRANIAL ATHEROSCLEROSIS-RELATED LARGE-VESSEL OCCLUSION. FRONT. NEUROL. 12: 608270. DOI: 10.3389/FNEUR.2021.608270. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BAEK J-H, JUNG C, KIM BM, HEO JH, KIM DJ, NAM HS, KIM YD, LIM EH, KIM J-H, KIM JY AND KIM JH (2021) COMBINATION OF RESCUE STENTING AND ANTIPLATELET INFUSION IMPROVED OUTCOMES FOR ACUTE INTRACRANIAL ATHEROSCLEROSIS-RELATED LARGE-VESSEL OCCLUSION. FRONT. NEUROL. 12: 608270. DOI: 10.3389/FNEUR.2021.608270 MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE AN OPTIMAL ENDOVASCULAR STRATEGY FOR LARGE-VESSEL OCCLUSION CAUSED BY IN SITU THROMBO-OCCLUSION (ICAS-LVO). THE AUTHORS REVIEWED 184 CASES OF PATIENTS TREATED FOR ICAS-LVO VIA MECHANICAL THROMBECTOMY OR MECHANICAL THROMBECTOMY WITH AN ALTERNATE APPROACH. OF THE 184 PATIENTS, THE AVERAGE AGE WAS 68 YEARS, 78 WERE FEMALE AND 106 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE. IN ADDITION, A SUCCESSFUL RECANALIZATION WAS ACHIEVED IN 168 PATIENTS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: MORTALITY WAS REPORTED AS A CLINICAL OUTCOME FOR 11 PATIENTS WHO UNDERWENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299744 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Death