BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 22005866 · Received May 12, 2025

    Report

    Report Number
    2029214-2025-01169
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 5, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    UDI-DI
    00847536026896
    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 SFR-6-30 (D002065); 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

    PRODUCT ANALYSIS: AS FOUND CONDITION: THE REBAR 27 CATHETER AND SOLITAIRE FR 6-30 STENT DEVICE WERE RETURNED FOR ANALYSIS INSIDE A SEALED BIOHAZARD BAG AND A SHIPPING BOX. DAMAGED LOCATION DETAILS: THE REBAR 27 CATHETER TIP AND MARKER WERE EXAMINED; NO DAMAGES WERE FOUND. THE CATHETER BODY WAS KINKED AT 32.5CM TO 35.4CM, AND AT 91.5CM FROM THE DISTAL TIP. NO VOIDS OR FLASHES WERE FOUND ON THE CATHETER HUB. THE SOLITAIRE FR 6-30 STENT¿S FINGER MARKERS WERE EXAMINED INSIDE THE INTRODUCER SHEATH. ALL FINGER MARKERS WERE CORRECTLY ALIGNED, AND NO DAMAGES WERE NOTED. THE STENT¿S WORKING LENGTH STRUTS ARE IN GOOD CONDITION, WHILE THE NON-WORKING LENGTH STRUTS ARE KINKED IN THE TEARDROP STRUT. THE PROXIMAL MARKER GLUE DOMES WERE DAMAGED. THE MARKER COIL WAS IN GOOD CONDITION. NO DAMAGE TO THE PUSHER WIRE WAS NOTED. NO OTHER ANOMALIES WERE FOUND. TESTING/ANALYSIS: THE REBAR 27 CATHETER¿S TOTAL AND USABLE LENGTHS WERE MEASURED WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND FOUND PATENT. THE CATHETER WAS TESTED BY RUNNING AN IN-HOUSE 0.026-INCH MANDREL THROUGH THE HUB WITHOUT ISSUE; HOWEVER, RESISTANCE WAS OBSERVED ALONG DAMAGED LOCATIONS. DUE TO ITS DAMAGED CONDITION, THE RETURNED SOLITAIRE FR 6-30 STENT DEVICE CANNOT BE USED FOR TESTING. 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 INFORMATION REGARDING A SOLITAIRE FR STENT RETRIEVER THAT HAD RESISTANCE DURING DELIVERY IN THE REBAR MICROCATHETER. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE VIA FEMORAL ACCESS. THE ACCESS VESSEL DIAMETER WAS 20MM. VESSEL TORTUOSITY WAS MODERATE.  IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE SOLITAIRE COULD NOT BE DELIVERED DUE TO RESISTANCE IN THE DISTAL END OF THE REBAR MICROCATHETER. IT WAS NOTED THAT THE DISTAL END OF THE CATHETER WAS BENT. THE VESSEL WAS NOTED TO BE TORTUOUS AND TORTUOSITY WAS SPECIFIED AS "MODERATE." TWO PASSES WERE MADE WITH THE DEVICE. BOTH THE CATHETER AND SOLITAIRE WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391915 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5082-145 B789623 00847536026896

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male