BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR4

    MDR report key: 24501459 · Received March 3, 2026

    Report

    Report Number
    2029214-2026-00356
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    November 28, 2025
    Report Date
    March 3, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    UDI-DI
    00763000256982
    PMA / PMN Number
    K183022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ANALYSIS FINDINGS, EVENT IS NOW REPORTABLE. PRODUCT ANALYSIS #(B)(4): EQUIPMENT USED: VIDEO INSPECTION SYSTEM (VIS) (M-81805), 203CM RULER (M-83361), CAMERA (PANASONIC LUMIX DMC-ZS5) .DRAWING(S) REFERENCED: N/A .AS FOUND CONDITION: THE SOLITAIRE FR4-4-20-05 STENT DEVICE WAS RETURNED FOR ANALYSIS STILL WITHIN ITS INTRODUCER SHEATH, INSIDE A SEALED BIOHAZARD BAG, AND A SHIPPING BOX. DAMAGED LOCATION DETAILS: THE SOLITAIRE FR4-4-20-05 STENT FINGER MARKERS WERE EXAMINED INSIDE THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS IN GOOD CONDITION. ALL THE FINGER MARKERS WERE CORRECTLY ALIGNED, AND NO DAMAGE WAS NOTED. THE STENT¿S WORKING LENGTH STRUTS WERE IN GOOD CONDITION, WHILE THE NON-WORKING LENGTH STRUTS WERE OBSERVED TO BE DAMAGED (KINKED). NO IRREGULARITIES WERE FOUND OUTSIDE THE PROXIMAL MARKER. THE MARKER COIL WAS IN GOOD CONDITION. THE PUSHER WIRE WAS OBSERVED TO BE BROKEN AT ~6.7CM FROM THE DISTAL TIP. NO OTHER ANOMALIES WERE FOUND. TESTING/ANALYSIS: THE SOLITAIRE FR4-4-20-05 STENT WAS PUSHED OUT OF THE INTRODUCER SHEATH WITHOUT DIFFICULTY. THE BROKEN END OF THE SOLITAIRE FR4-4-20-05 PUSHER WIRE WAS SENT OUT FOR SCANNING ELECTRON MICROSCOPY (SEM) FAILURE ANALYSIS. THE SCANNING ELECTRON MICROSCOPY (SEM) TEST RESULTS INDICATE THAT THE BROKEN END FAILED VIA FATIGUE THEN OVERLOAD. CONCLUSION: BASED ON THE REPORTED INFORMATION AND DEVICE ANALYSIS, THE CUSTOMER¿S ¿FAILURE TO OPEN¿ REPORT COULD NOT BE CONFIRMED AS THE STENT OF THE RETURNED SOLITAIRE FR4-4-20-05 DEVICE WAS OPEN, AND THE NON-WORKING LENGTH STRUTS WERE OBSERVED TO BE DAMAGED (KINKED). THE LIKELY CAUSE OF FAILURE TO OPEN COULD BE DAMAGE TO THE STENT. HOWEVER, THE CAUSE OF THE STENT DAMAGE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF STENT DAMAGE COULD INCLUDE AN INCOMPATIBLE/DAMAGED CATHETER, VESSEL TORTUOSITY, AND A LACK OF CONTINUOUS SALINE/HEPARINIZED SALINE FLUSH DURING THE PROCEDURE. IN THIS EVENT, THE CUSTOMER REPORTED THAT THE VESSEL TORTUOSITY WAS MINIMAL, RULING OUT VESSEL TORTUOSITY AS A POSSIBLE CAUSE. THEREFORE, AN INCOMPATIBLE/DAMAGED CATHETER AND A LACK OF CONTINUOUS SALINE/HEPARINIZED SALINE FLUSH DURING THE PROCEDURE COULD HAVE CONTRIBUTED TO THE STENT DAMAGE. IN ADDITION, THE PUSHER WIRE OF THE RETURNED SOLITAIRE FR4-4-20-05 DEVICE WAS FOUND BROKEN. THE BROKEN END FAILED VIA FATIGUE THEN OVERLOAD. HOWEVER, THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. POSSIBLE CAUSES COULD INCLUDE THE PRESENCE OF A PRE-EXISTING EXTRA/INTRACRANIAL STENOSIS OR CALCIFIED PLAQUE, PRESENCE OF HARD CLOTS/THROMBUS, THE NUMBER OF PASSES MADE WITH THE DEVICE, OR A NEW CATHETER WAS NOT USED WITH EACH SOLITAIRE DEVICE. IN THIS EVENT, THE CUSTOMER REPORTED THAT A SINGLE PASS WAS MADE WITH THE SOLITAIRE DEVICE, RULING OUT THE NUMBER OF PASSES AS A POSSIBLE CAUSE. THEREFORE, THE PRESENCE OF A PRE-EXISTING EXTRA/INTRACRANIAL STENOSIS OR CALCIFIED PLAQUE, THE PRESENCE OF HARD CLOTS/THROMBUS, OR A NEW CATHETER WAS NOT USED WITH EACH SOLITAIRE DEVICE COULD HAVE CONTRIBUTED TO THE BROKEN PUSHER WIRE. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. 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 THE PROXIMAL END OF THE SOLITAIRE STENT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT DURING ENDOVASCULAR THROMBECTOMY (EVT) USING A SOLITAIRE X 4×20 (LOT: D041263), NO THROMBUS WAS RETRIEVED ON THE FIRST PASS. WHILE PREPARING FOR THE SECOND ATTEMPT, A DEFECT WAS NOTED ON THE PROXIMAL END OF THE STENT RETRIEVER DURING FLUSHING THE PROXIMAL PORTION DID NOT FULLY EXPAND. DUE TO CONCERNS ABOUT THE RETRIEVAL PERFORMANCE, THE DEVICE WAS REPLACED WITH A NEW SOLITAIRE X 4×20 (LOT: D052009), AND THROMBECTOMY WAS SUCCESSFULLY COMPLETED. THE PROXIMAL PORTION OF THE STENT FAILED TO OPEN AND WAS REMOVED FROM THE PATIENT. HOW LONG THE STENT WAS DEPLOYED IN THE CLOT IS UNKNOWN. THERE WAS DAMAGE IN THE PROXIMAL SECTION, AND THE STENT WAS NOT POSITIONED IN A BEND. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE PROXIMAL END NOT OPENING COULD NOT BE DETERMINED. THE PATIENT¿S BASELINE STATUS, INCLUDING TICI AND NIHSS SCORES, WAS UNKNOWN. THE PATIENT¿S POST-THROMBECTOMY CONDITION WAS ALSO UNAVAILABLE AS THE PHYSICIAN IS CONTINUING TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563317 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR4-4-20-05 D041263 00763000256982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown