BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBAR

    MDR report key: 21806351 · Received April 9, 2025

    Report

    Report Number
    2029214-2025-00926
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 3, 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

    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

    CONTINUATION OF D10: PRODUCT ID SAB-6-30 (LOT: B547930); PRODUCT TYPE: ; IMPLANT DATE ; EXPLANT DATE 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

    ADDITIONAL INFORMATION RECEIVED REPORTED A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING SOLITAIRE AB (SAB) RESISTANCE IN THE REBAR MICROCATHETER DURING DELIVERY. THE PATIENT WAS UNDERGOING AN INTERNAL CAROTID ARTERY (ICA) C6 SEGMENT THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED. NIHSS, MRS, AND TICI SCORES WERE NOT AVAILABLE EITHER FOR PATIENT'S BASELINE OR POST-OPERATIVE. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE REBAR MICROCATHETER WAS DELIVERED IN PLACE AND DELIVERY OF THE SAB STENT RETRIEVER WAS INITIATED. HOWEVER, THE SAB EXPERIENCED RESISTANCE AND COULD NOT BE ADVANCED PAST THE MIDDLE SEGMENT OF THE MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S VESSEL WAS TORTUOUS. NO ACTUAL THROMBECTOMY PASS WAS COMPLETED WITH THE COMPLAINT DEVICE. THE DEVICE WAS REMOVED AND AN ATTEMPT WAS MADE TO TRY AND ADVANCE IT IN VITRO BUT THE RESISTANCE STILL OCCURRED SO THE SAB WAS REPLACED WITH ANOTHER OF THE SAME MODEL 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
    1469808 REBAR CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5081-153 B739879

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male