BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM

    MDR report key: 9174610 · Received October 10, 2019

    Report

    Report Number
    2029214-2019-01013
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 10, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PART: THE 2 PRODUCT LINES THAT WERE AFFECTED ARE THE AXIUM PRIME ES COILS IN SIZES 3MM-3.5MM AND THE AXIUM BARE COILS IN THE 3MM-3.5MM SIZES. PART PMA / 510(K) #: AXIUM COIL - K081465, AXIUM PRIME - K151447 THE AXIUM COIL WILL NOT BE RETURNED FOR EVALUATION AS IT IMPLANTED IN THE PATIENT; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. PER THE AXIUM DETACHABLE COIL AND AXIUM I.D. (INSTANT DETACHER) INSTRUCTIONS FOR USE (IFU): ¿IF THE COIL DOES NOT DETACH AFTER 3 AT TEMPTS, DISCARD THE I.D. (INSTANT DETACHER) AND REPLACE WITH A NEW I.D. (INSTANT DETACHER). ALSO, ¿IN THE RARE EVENT THAT THE COIL DOES NOT DETACH AND CANNOT BE REMOVED FROM THE IMPLANT DELIVERY PUSHER, USE THE FOLLOWING STEPS FOR DETACHMENT. A. GRIP THE HYPOTUBE APPROXIMATELY 5 CM DISTAL OF THE POSITIVE LOAD INDICATOR AT THE HYPOTUBE BREAK INDICATOR AND BEND THE IMPLANT DELIVERY PUSHER JUST DISTAL TO THE HBI 180 DEGREES. B. NEXT STRAIGHTEN THE PUSHER BACK, CONTINUE BENDING AND STRAIGHTENING UNTIL THE PUSHER TUBING OPENS EXPOSING THE RELEASE ELEMENT. C. GENTLY SEPARATE THE PROXIMAL AND DISTAL ENDS OF THE OPEN PUSHER. THEN, UNDER FLUOROSCOPY, PULL THE PROXIMAL PORTION OF THE IMPLANT DELIVERY PUSHER APPROXIMATELY 2-3 CM TO CONFIRM IMPLANT DETACHMENT PER IFU.¿ RELATED MDRS FOR THIS EVENT: 2029214-2019-01012, 2029214-2019-01014, 2029214-2019-01015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOUR COILS WOULD NOT DETACH WITH TWO DIFFERENT INSTANT DETACHERS OR USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). THESE ALL FOUR COILS DETACHED INSIDE THE CATHETER DURING REMOVAL FROM THE CATHETER. THE COILS WERE IMPLANTED AT INTENDED LOCATION WITH USING NEW COIL EACH TIME. THE PATIENT WAS UNDERGOING COILING TREATMENT FOR AN ANEURYSM. IT WAS REPORTED THAT COILS WERE PLACED INTO ANEURYSM. DETACHMENT MALFUNCTIONED ON 4 COILS OUT OF A TOTAL OF 10. AFTER SECOND DETACHER WAS ATTEMPTED, PHYSICIAN ATTEMPTED MANUAL DETACHMENT, HOWEVER THAT THE COILS FAILED TO DETACH AS WELL. COILS DETACHED INSIDE CATHETER AS PHYSICIAN ATTEMPTED TO REMOVE MALFUNCTIONED COILS. DEFECTIVE COILS WERE THEN PUSHED BACK INTO ANEURYSM USING NEW COIL. THIS HAPPENED A TOTAL OF 4 TIMES ACROSS 2 DIFFERENT COIL FAMILIES. ALL COILS WERE IMPLANTED EVEN AFTER MALFUNCTION. NO HARM DONE TO PATIENT. THERE ARE NO RETURNED ITEMS OR PACKAGING DUE TO COILS BEING IMPLANTED. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971704 AXIUM DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1