BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 22307899 · Received June 23, 2025

    Report

    Report Number
    2029214-2025-01444
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 18, 2025
    Report Date
    June 23, 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 SAB-6-30 (LOT: D011802); 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 AB (SAB) THAT HAD RESISTANCE DURING DELIVERY IN A REBAR 18 MICROCATHETER. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE WHICH IS OFF-LABEL USE FOR THE SAB. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE STENT WAS ABLE TO BE PUSHED OUT OF THE SHEATH. WHILE ADVANCING THE SAB THROUGH THE PROXIMAL SEGMENT OF THE MICROCATHETER, RESISTANCE WAS FELT. WHEN THE SAB WAS WITHDRAWN, THE STENT TO DELIVERY WIRE CONNECTION POINT WAS FOUND VISIBLY BENT. THE SAB WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755825 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-REBAR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...