BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 19637238 · Received June 28, 2024

    Report

    Report Number
    2029214-2024-01150
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    April 12, 2024
    Report Date
    June 28, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF SFR-6-30, LOT NO:B495086 ¿ AS FOUND CONDITION: THE REBAR-18 CATHETER AND SOLITAIRE FR REVASCULARIZATION DEVICE WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING B OX AND A PLASTIC BIO-POUCH. ¿ DAMAGE LOCATION DETAILS: NO DAMAGES WERE FOUND WITH THE REBAR-18 CATHETER HUB. THE REBAR-18 CATHETER BODY WAS FOUND SEPARATED/BROKEN AT ~145.9CM FROM THE PROXIMAL END OF THE CATHETER HUB, ~15.0CM FROM THE CATHETER DISTAL TIP. THE SEPARATED REBAR-18 CATHETER BODY WAS RETAINED BY THE INNER WIRE. THE SOLITAIRE FR STENT WAS FOUND EXTENDING OUT FROM WITHIN THE CATHETER DISTAL SEPARATED END. NO DAMAGES WERE FOUND WITH THE REBAR-18 CATHETER DISTAL TIP/MARKER. THE SOLITAIRE FR STENT WAS REMOVED FROM WITHIN THE CATHETER DISTAL SEPARATED END. THE SOLITAIRE FR STENT WAS FOUND TO HAVE SEPARATED FROM ITS PUSHER AT THE STENT¿S PROXIMAL MARKER. THE PUSHER WAS NOT RETURNED. THE SOLITAIRE FR STENT NON-WORKING TEAR DROP STRUTS WERE FOUND BENT. THE SOLITAIRE FR STENT WORKING LENGTH STRUTS WERE FOUND TO BE IN GOOD CONDITION. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿MARKER BAND DISLODGED¿ REPORT COULD NOT BE CONFIRMED AS NO DAMAGES WERE FOUND WITH THE REBAR-18 CATHETER DISTAL TIP/MARKER. HOWEVER, THE RETURNED REBAR-18 CATHETER BODY WAS FOUND SEPARATED/BROKEN. IN ADDITION, THE SOLITAIRE FR STENT WAS FOUND DAMAGED (BENT) AND WAS FOUND TO HAVE SEPARATED FROM ITS PUSHER. DAMAGES TO THE REBAR-18 CATHETER AND SOLITAIRE FR STENT CAN OCCUR IF ADVANCED/RETRIEVED AGAINST RESISTANCE. IT IS LIKELY THAT THE USE OF AN INCOMPATIBLE CATHETER CONTRIBUTED TO THE DAMAGES. THE REBAR-18 CATHETER HAS A LABELED INNER DIAMETER (ID) OF 0.021¿. AS PER THE SOLITAIRE FR INSTRUCTIONS FOR USE (IFU), ¿SOLITAIRE¿ FR REVASCULARIZATION DEVICE WITH THE SFR-6-20 AND SFR-6-30 REFERENCE NUMBERS SHOULD BE INTRODUCED ONLY THROUGH A MICROCATHETER WITH A MINIMUM INSIDE DIAMETER OF 0.027 INCHES.¿ 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

    A DEVICE WAS RETURNED WITH NO KNOWN COMPLAINT. ANALYSIS OF THE DEVICE FOUND A NON-CONFORMANCE. MEDTRONIC RECEIVED INFORMATION THAT THE MARKER TIP OF THE REBAR CATHETER HAD BEEN DISLODGED. WHEN USING A STENT TO REMOVE THROMBUS, THE SECOND STENT DELIVERY WAS PERFORMED, AND IT WAS FOUND THAT THE MAKER AT THE TIP END OF THE STENT FELL OFF, SO THE ENTIRE SYSTEM WAS WITHDRAWN AND REPLACED AGAIN. THE CATHETER WAS FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN ISCHEMIC STRIKE IN THE MIDDLE CEREBRAL ARTERY. THE PATIENT WAS UNDERGOING A THROMBECTOMY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20F. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE MARKER BAND DISLODGEMENT WAS NOT DETERMINED. THE ANATOMICAL LOCATION OF THE MARKER BAND WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207175 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR-6-30 B495086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male