BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 19625796 · Received June 27, 2024

    Report

    Report Number
    2029214-2024-01146
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    July 8, 2023
    Report Date
    June 27, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 105-5081-153 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: JIANMEI CAI, GUANGJUN XI, ZHENG DAI.. COMPARISON OF CLINICAL EFFICACY AND SAFETY BETWEEN INTRAVENOUS THROMBOLYSIS AND ENDOVASCULAR THERAPY IN PATIENTS WITH ACUTE LARGE VESSEL OCCLUSION STROKE OF THE POSTERIOR CIRCULATION. SIGNA VITAE. 19(4):129-134. 2023. DOI:10.22514/SV.2023.055 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF INTRACRANIAL HEMORRHAGE AND PULMONARY INFECTION IN ASSOCIATION WITH SOLITAIRE THROMBECTOMY USING THE SOLITAIRE STENT AND REBAR 18 CATHETER. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE OUTCOMES OF INTRAVENOUS THROMBOLYTIC TREATMENT TO ENDOVASCULAR TREATMENT IN PATIENTS WITH POSTERIOR ISCHEMIC STROKES. THE AUTHORS REVIEWED 50 CASES OF PATIENTS TREATED FOR POSTERIOR ISCHEMIC STROKE. TWENTY-FIVE PATIENTS RECEIVED TISSUE PLASMINOGEN ACTIVATOR (TPA) AND THE OTHER 25 UNDERWENT A MECHANICAL THROMBECTOMY USING THE SOLITAIRE STENT AND REBAR 18 CATHETER. OF THE 25 PATIENTS WHO UNDERWENT THE MECHANICAL THROMBECTOMY, THE AVERAGE AGE WAS 65 YEARS, 10 WERE FEMALE AND 15 WERE MALE. IT WAS FOUND THAT PATIENTS UNDERGOING ENDOVASCULAR TREATMENT HAD SIGNIFICANTLY BETTER PROGNOSIS THAN THE PATIENT'S RECEIVING THROMBOLYTIC TREATMENT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE STENT OR REBAR CATHETER. IN ADDITION, 1 PATIENT HAD AN MTICI SCORE OF GRADE 1, 2 PATIENTS HAD AN MTICI SCORE OF GRADE 2A, 9 PATIENTS HAD A MTICI SCORE OF 2B, AND 13 PATIENTS HAD AN MTICI SCORE OF 13. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: INTRACRANIAL HEMORRHAGE IN 2 PATIENTS PULMONARY INFECTION IN 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481827 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11...