BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 21875768 · Received April 21, 2025

    Report

    Report Number
    2029214-2025-01034
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 17, 2025
    Report Date
    May 8, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Product Problem
    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 (B737999); PRODUCT TYPE: N/A PRODUCT ID 105-5081-153 (B773591); PRODUCT TYPE. 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.

    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

    MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR ENCOUNTERED RESISTANCE AND THE PUSHROD BECAME KINKED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A LEFT MIDDLE CEREBRAL ARTERY ISCHEMIC STROKE. PATIENT DETAILS: MRS: BASELINE 3, MRS: PROCEDURE 3, NIHSS SCORE: BASELINE 18, NIHSS SCORE: POST PROCEDURE 3, TICI SCORE: BASELINE 0, TICI SCORE: POST PROCEDURE 3. IV TPA WAS NOT CONTRAINDICATED. ONE PASS WAS MADE WITH THE DEVICE. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. STROKE ONSET TO REPERFUSION TIME WAS 6. DURING AN INTERVENTIONAL SURGERY FOR INTRACRANIAL LARGE VESSEL OCCLUSION. ANGIOGRAPHY SHOWED THAT THE OCCLUDED PART WAS THE LEFT MIDDLE CEREBRAL ARTERY. AVIGO GUIDEWIRE REBAR18 (LOT NUMBER B737999), AFTER THE MICROCATHETER WAS PLACED, THE LENGTH OF THE THROMBUS WAS CONFIRMED, AND THE SWIM TECHNIQUE WAS USED TO REMOVE THE THROMBUS. THE INTRACRANIAL THROMBUS REMOVAL STENT SFR-6-30 (LOT NUMBER D001478) WAS HYDRATED AND READY TO BE INSERTED INTO THE STENT ALONG THE TAIL SECTION OF THE MICROCATHETER. THERE WAS GREAT RESISTANCE WHEN THE STENT TIP REACHED THE TAIL END OF THE MICROCATHETER. THE DIRECTOR THEN REPLACED THE MICROCATHETER WITH A NEW ONE, REBAR18 (LOT NUMBER B773591), AND TRIED TO DELIVER THE STENT AGAIN. HOWEVER, THE STENT STILL COULD NOT PASS THROUGH. AT THIS TIME, IT WAS FOUND THAT THE TIP OF THE STENT DELIVERY ROD HAD BEEN KINKED AND DEFORMED. THE DIRECTOR REPLACED THE THROMBECTOMY STENT WITH A NEW ONE, SFR-6-30 (LOT NUMBER D001478), WHICH PASSED SMOOTHLY AND THE OPERATION WENT SMOOTHLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE SOLITAIRE RESISTANCE/DAMAGE WAS UNDETERMINED, SUSPECTED QUALITY PROBLEM OF THE STENT. A CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518589 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 D001478

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male