BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 20584566 · Received October 31, 2024

    Report

    Report Number
    2029214-2024-02046
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    February 13, 2024
    Report Date
    October 31, 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 UNK-NV-ONYX (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-ECHELON (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-HYPERFORM (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: ZHOU Y, LI Q, LI J, LIU J. EMBOLIZATION OF A NON-GALENIC PIAL ARTERIOVENOUS FISTULA WITH ASSISTANCE OF A SOLITAIRETM STENT: CASE REPORT. TURK NEUROSURG 34(2):362-366 2024. 10.5137/1019-5149.JTN.29642-20.2 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

    LITERATURE WAS REVIEWED REGARDING A STUDY AIMED TO DESCRIBE A NOVEL ENDOVASCULAR STRATEGY TO HELP CONTROL BLOOD FLOW USED SUCCESSFULLY TO TREAT AN INFANT WITH HIGHFLOW PIAL ARTERIOVENOUS FISTULA (AVF). THE CASE WAS A SINGLE-HOLE HIGH-FLOW NONGALENIC PIAL ARTERIOVENOUS FISTULA (AVF) DIAGNOSED IN A 2.5 YEAR-OLD INFANT. MEDTRONIC DEVICES INCLUDED SOLITAIRE, ONYX, ECHELON, AND HYPERFORM. AFTER COIL PACKING FAILURE DESPITE TEMPORAL BALLOON OCCLUSION, THEY DEPLOYED A SOLITAIRETM STENT IN THE FISTULA. BY TWISTING WITH DETACHABLE COILS, THEY ACHIEVED SATISFACTORY BLOOD FLOW CONTROL, AND OBLITERATION OF THE FISTULA WAS ACHIEVED WITH ONYX INJECTION. AFTER EMBOLIZATION, ONE DURAL ARTERIOVENOUS FISTULA WAS FOUND IN THE SINUS CONFLUENCE AND WAS SCHEDULED FOR STAGED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984123 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Required Intervention SEE H11...