BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 22576380 · Received July 23, 2025

    Report

    Report Number
    9612501-2025-01971
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 18, 2025
    Report Date
    August 22, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    UDI-DI
    00847536026834
    PMA / PMN Number
    K093750
    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 SAB-6-30 (LOT: D014681); PRODUCT TYPE: PRODUCT ID UNK-NV-REBAR (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID UNK-NV-REBAR (UNKNOWN SERIAL/LOT); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A 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

    B5. UPDATED WITH ADDITIONAL INFORMATION RECEIVED. D3/D4 UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED. H6. CODING UPDATED BASED ON AVAILABLE INFORMATION. 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 PATIENT WAS UNDERGOING WHOLE BRAIN ANGIOGRAPHY AND THROMBECTOMY OPERATION FOR ISCHEMIC STROKE M2 SEGMENT OCCLUSION TREATMENT. THE SITE OF INTRACRANIAL VASCULAR OCCLUSION WAS DETERMINED BY ANGIOGRAPHY. IT WAS NOTED THAT THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 40MIN IT WAS REPORTED THAT THE GUIDE SHEATH, NEUROVASCULAR GUIDEWIRE, THROMBUS ASPIRATION CATHETER, REBAR18 MICROCATHETER, AND INTRACRANIAL VASCULAR STENT SAB-6-30 WERE SELECTED. AFTER THE PREPARATION WORK WAS COMPLETED, THE REBAR 18 MICROCATHETER WAS SUCCESSFULLY PUT IN PLACE. THE SURGEON SELECTED THE INTRACRANIAL VASCULAR STENT SAB-6-30 AND MOISTENED IT IN VITRO. DURING THE DELIVERY PROCESS OF SLOWLY PUSHING THE STENT, IT WAS FOUND THAT THE RESISTANCE TO PUSHING THE STENT GRADUALLY INCREASED AT THE PROXIMAL SECTION OF THE CATHETER, AND FINALLY THE STENT COULD NOT BE PUSHED FURTHER. IT WAS FOUND THAT THE TAIL OF THE STENT WAS CLOGGED AT THE TAIL OF THE MICROCATHETER. THE SURGEON TRIED MANY TIMES BUT FAILED TO PUSH IT. TWO NEW REBAR18 MICROCATHETERS WERE USED INSTEAD FOR DELIVERY, BUT THEY COULD NOT BE PUSHED IN PLACE. BECAUSE THE PATIENT WAS ALREADY IN A COMA AND THE SITUATION WAS CRITICAL, A NEW SAB-6-30 STENT W AS FINALLY USED INSTEAD, SUCCESSFULLY PUSHED IN PLACE, AND THE THROMBUS WAS REMOVED. AFTER THE OPERATION, THE SURGEON THOUGHT THAT THIS SITUATION HAD NEVER OCCURRED WHEN USING SAB-6-30 BEFORE. AFTER REPLACING THE MICROCATHETER, IT STILL COULD NOT BE PUSHED NORMALLY, AND THE SURGEON FILED A COMPLAINT THAT IT WAS A PRODUCT QUALITY ISSUE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S BASELINE NIHSS WAS 12 AND POST PROCEDURE TICI NIHSS HAD IMPROVED TO 3. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE PER THE IFU. THERE WAS NOT KINK/DAMAGE OBSERVED TO THE CATHETER(S) AFTER REMOVAL. ALL THE ATTEMPTED REBAR 18 MICROCATHETERS WERE FROM THE SAME MODEL/LOT. IT SHOULD BE NOTED THAT PER THE IFU, THE SAB-6-30 IS RECOMMENDED FOR USE WITH A CATHETER THAT HAS AN INNER DIAMETER OF 0.027 INCHES AND IS THEREFORE NOT COMPATIBLE/OFF LABEL USE WITH REBAR 18 CATHETER WHICH HAS AN INNER DIAMETER OF AS IT HAD A LABELED INNER DIAMETER OF 0.021 INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2809028 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5081-153 B622015 00847536026834

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female SEE H11.