BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR4

    MDR report key: 11253269 · Received January 29, 2021

    Report

    Report Number
    2029214-2021-00117
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    December 5, 2020
    Report Date
    January 29, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    UDI-DI
    00847536034730
    PMA / PMN Number
    K183022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SOLITAIRE X STENT DEVICE (MODEL: SFR4-6-40-10 LOT: B042974) FOUND THAT THE INNER DIAMETER OF THE SOFIA CATHETER WAS MEASURED TO BE 0.0515" AT THE HUB AND 0.0510" AT THE DISTAL TIP, THEREFORE, THE SOFIA CATHETER WAS FOUND TO BE COMPATIBLE FOR USE WITH SOLITAIRE X STENT DEVICE. BLOOD WAS FOUND WITHIN THE SOFIA CATHETER HUB AND LUMEN. THE SOFIA CATHETER WAS FOUND KINKED AT 5.06 CM FROM THE DISTAL END. A 0.051" MANDREL WAS INSERTED INTO THE CATHETER HUB, THROUGH THE CATHETER BODY AND BECAME STUCK AT ~8.0 CM FROM THE DISTAL END. BLOOD WAS FOUND AT THIS LOCATION OF THE CATHETER. THE SOLITAIRE X STENT WAS FOUND SEPARATED FROM THE PUSHER AND STUCK WITHIN THE DISTAL END OF THE SOFIA CATHETER. THE CATHETER WAS CUT TO EXTRACT THE SOLITAIRE X STENT. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PUSHER OR MARKER COIL. THE PUSHER DISTAL WIRE WAS FOUND BROKEN FROM THE PUSHER UNDER THE MARKER COIL. THE MARKER COIL WAS REMOVED TO ACCESS THE BROKEN END OF THE DISTAL WIRE (WIRE A). THE STENT FINGER MARKERS WERE EXAMINED AND FOUND TO BE UNDAMAGED. THE STENT WORKING LENGTH STRUTS WERE FOUND IN GOOD CONDITION. THE STENT NON-WORKING (TEAR DROP) LENGTH STRUTS WERE FOUND KINKED. THE SOLITAIRE X STENT WAS FOUND SEPARATED FROM THE PUSHER AT THE KEYHOLE MARKER BAND. THE DISTAL WIRE APPEARS TO BE BROKEN WITHIN THE MARKER BAND. ACETONE WAS USED TO DISSOLVE THE DYMAX GLUE TO ACCESS THE DISTAL WIRE. BOTH DISTAL WIRE BROKEN ENDS WERE SENT OUT FOR SEM IMAGING AND ANALYSIS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER'S REPORTS OF "RESISTANCE DURING DELIV/RETRIEVAL" AND "KINK/DAMAGE" WAS CONFIRMED. THE STENT WAS FOUND KINKED AT THE NON-WORKING LENGTH STRUTS. POSSIBLE CAUSES ARE DAMAGED CATHETER, PATIENT VESSEL TORTUOSITY, USER USES SAME MICRO CATHETER WITH MULTIPLE SOLITAIRE DEVICES, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, USER DOES NOT MAINTAIN THE CORRECT FLUSH RATE, RHV LOOSE DURING DELIVERY OR INTRODUCER SHEATH DAMAGE. AS BLOOD WAS FOUND THROUGHOUT THE CATHETER AND IN THE HUB, IT IS LIKELY THAT INSUFFICIENT FLUSHING WAS PERFORMED DURING THE PROCEDURE. THE PUSHWIRE WAS FOUND BROKEN AT THE DISTAL WIRE IN TWO LOCATION. THE SEM SUMMARY: DIMPLE FEATURES CONSISTENT WITH TENSILE OVERLOAD TYPE FAILURES ARE VISIBLE ON BOTH ENDS. WIRE THINNING IS VISIBLE AT THE WIRE A BROKEN END, ALONG WITH A PATCH OF FLATTENED AREA. POSSIBLE CAUSES FOR THIS FAILURE ARE PATIENT STENOSIS, VESSEL TORTUOSITY, PRE-EXISTING STENT, NUMBER OF PASSES MADE WITH DEVICE OR A NEW MICROCATHETER WAS NOT USED WITH EACH SOLITAIRE. THE BLOOD FOUND WITHIN THE SOFIA CATHETER COULD HAVE ALSO CONTRIBUTED TOWARDS RESISTANCE AND SUBSEQUENT BREAKING OF THE PUSHER DISTAL WIRE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE STENT BECAME STRETCHED AND STUCK INSIDE THE INTERMEDIATE CATHETER; THE SOLITAIRE RESISTANCE OCCURRED ABOUT 2-3 CM INTO THE CATHETER. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE TIP OF THE SHEATH WAS SECURED IN THE HUB OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT OF AN ICA-MCA OCCLUSION. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL AND THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICE: SOFIA 5FR 125CM CATHETER ***EVENT REPORTABLE DUE TO ANALYSIS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147790 SOLITAIRE FR4 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 SFR4-6-40-10 B042974 00847536034730

    Patients

    Seq Age Sex Outcome Treatment
    1