BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 21007811 · Received December 23, 2024

    Report

    Report Number
    2029214-2024-02425
    Event Type
    Death
    Date Received
    December 23, 2024
    Date of Event
    September 12, 2022
    Report Date
    December 23, 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

    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

    CHEN, C.-G., GAO, B.-L., YANG, C.-B., HAO, X.-H., REN, C.-F., YANG, L., HAN, Y.-F., CAO, Q.-Y.; JOURNAL OF MEDICINE; 2023; 102:4; SAFETY AND EFFECTS OF ENDOVASCULAR TREATMENT OF BASILAR TIP ANEURYSMS IN PATIENTS WITH MOYAMOYA DISEASES; DOI.ORG/10.1097/MD.0000000000032777 STUDY TITLE OR OBJECTIVE: THE DOCUMENT REVIEWS LITERATURE REGARDING THE USE OF EMBOLIZATION TECHNIQUES IN TREATING ANEURYSMS. THE SPECIFIC TIME FRAME FOR THIS STUDY WAS BETWEEN 2014 AND 2020. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION, INCLUDING THE ENTERPRISE STENT (N-8), SOLITAIRE EZ (N=6), AND LVIS STENT (N=8). HOWEVER, THE SPECIFIC MANUFACTURERS ARE NOT MENTIONED. THE SOLITAIRE IS A MEDTRONIC DEVICE. DEATHS OCCURRED IN THE STUDY POPULATION. THERE WAS ONE DEATH DUE TO ANEURYSM RUPTURE DURING THE TREATMENT. ADVERSE EVENTS. INTRAPROCEDURAL COMPLICATIONS OCCURRED IN 3 PATIENTS: ANEURYSM RUPTURE IN 1 PATIENT WITH A LARGE ANEURYSM (13MM IN DIAMETER), LEADING TO DEATH OF THE PATIENT, AND STENT THROMBOSIS IN 2 (WITH 1 LARGE ANEURYSM OF 15MM IN SIZE AND THE OTHER SMALL ANEURYSM OF 10MM IN SIZE) WHICH WAS SUCCESSFULLY TREATED WITH THROMBOLYSIS. FOLLOW UP AT 6-26 MONTHS: ANEURYSM OCCLUSION DEGREE WAS RAYMOND¿ROY GRADE I IN 21 PATIENTS, GRADE II IN 4, AND GRADE III IN 2. ANEURYSM RECURRENCE WAS FOUND IN 4 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627650 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death