BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 20932136 · Received December 13, 2024

    Report

    Report Number
    2029214-2024-02305
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Product Problem
    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

    MEDTRONIC RECEIVED A REPORT THAT THE SFR6-30 STENT COULD NOT PASS THROUGH THE PROXIMAL SECTION OF THE REBAR27 MICROCATHETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. STROKE ONSET TO REPERFUSION TIME WAS 120. IT WAS REPORTED THAT THE PATIENT WAS CONSIDERED TO HAVE ACUTE OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY AFTER ANGIOGRAPHY. THE SURGEON THEN CONSIDERED USING THE THROMBECTOMY STENT SFR-6-30 TO REMOVE THE THROMBUS THROUGH THE MICROCATHETER REBAR-27. AFTER THE NORMAL HYDRATION PROCESS, THE SFR-6-30 WAS TO BE PUSHED INTO THE MICROCATHETER THROUGH THE Y VALVE. AFTER THE STENT SHEATH WAS PLACED IN THE Y VALVE, THE STENT WAS DELIVERED. THE SURGEON FELT OBVIOUS PUSH RESISTANCE AND IMMEDIATELY WITHDREW THE STENT TOGETHER WITH THE OUTER SHEATH. INSPECTION FOUND THAT THE DISTAL END OF THE STENT PUSH ROD WAS BENT. CONSIDERING THAT THE PROBLEM PRODUCT CAUSED THE FAILURE TO PUSH, THE SURGEON THEN REPLACED ANOTHER 6-30 STENT TO COMPLETE THE SUBSEQUENT EMERGENCY SURGERY AND REQUESTED THAT THE FIRST SFR-6-30 STENT NOT BE CHARGED. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD FOR OBSERVATION. IT WAS NOTED THAT RESISTANCE OCCURRED DURING PREPARATION. THE STENT WAS NOT ABLE TO BE PUSHED OUT OF THE SHEATH. THE SHEATH WAS NOT DAMAGED. 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. ADDITIONAL INFORMATION RECEIVED REPORTED THAT STROKE ONSET TO REPERFUSION TIME WAS 120 MINUTES. THE TIP OF THE SHEATH WAS SECURED IN THE HUB OF THE MICROCATHETER. THE RHV WAS SECURED DURING DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893981 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male