BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 22212180 · Received June 16, 2025

    Report

    Report Number
    2029214-2025-01381
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 26, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    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 (B799650); 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

    H6: IT WAS REPORTED THAT THE REBAR CATHETER WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. 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 DURING THE DELIVERY, THE SOLITAIRE SFR STENT ENCOUNTERED RESISTANCE AT THE REBAR CATHETER IN DISTAL SECTION. THE PATIENT WAS UNDERGOING TREATMENT FOR THROMBECTOMY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE STROKE ONSET TO REPERFUSION TIME WAS 100 MINUTES. THE VESSEL WAS NOT TORTUOUS IT WAS REPORTED THAT WHILE USING THE REBAR18 MICROCATHETER TO DELIVER THE SFR-6-30 THROMBECTOMY STENT, THE STENT COULD NOT BE ADVANCED TO THE DISTAL END. THE SURGEON REPORTED SIGNIFICANT RESISTANCE. AFTER WITHDRAWING THE STENT AND ATTEMPTING DELIVERY AGAIN, IT STILL COULD NOT BE ADVANCED. THE SURGEON REPLACED IT WITH ANOTHER SFR STENT, WHICH SUCCESSFULLY PASSED THROUGH. THE SURGEON DECIDED NOT TO CHARGE FOR THE INITIAL STENT AND REQUESTED A COMPLAINT TO BE FILED FOR THE 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 24. POST-THROMBECTOMY CONDITION NIHSS 6. CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE OBSERVED TO THE REBAR18 AND STENT AFTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040196 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5081-153 D007552

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male SEE H11...