BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BARE HELIX

    MDR report key: 6960009 · Received October 18, 2017

    Report

    Report Number
    2029214-2017-01167
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    October 8, 2017
    Report Date
    December 28, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRD
    PMA / PMN Number
    K081465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE AXIUM PRIME PUSHWIRE WAS RETURNED WITHOUT THE INTRODUCER SHEATH; THE IMPLANT COIL WAS ALREADY DETACHED. THE PUSHWIRE WAS FOUND TO BE BENT NEAR THE PROXIMAL END. UNDER THE MICROSCOPE, THE COIN WAS FOUND TO BE LOCATED AGAINST THE LUMEN STOP, THE SHIELD COIL WAS FOUND TO BE PRESENT, AND THE DETACH ELEMENT WAS FOUND TO BE STILL CONNECTED TO, AND EXTENDING OUT FROM THE DISTAL END OF THE PUSHWIRE. THE IMPLANT COIL WAS FOUND TO BE BROKEN FROM THE COIL SHELL AT THE COIL SHELL WELD. THE DETACHED AND STRETCHED IMPLANT COIL WAS FOUND TO BE STUCK AND EXTENDING OUT FROM THE DISTAL END OF A NON-MEDTRONIC MICROCATHETER. THE POLYPROPYLENE FILAMENT WAS FOUND TO BE BROKEN. DUE TO THIS DAMAGED CONDITION, THE AXIUM PRIME COIL COULD NOT BE TESTED WITH AN IN-HOUSE MICROCATHETER BASED ON RETURNED PRODUCT EVALUATION AND EVENT DESCRIPTION, THE CUSTOMER REPORTS OF "COIL STRETCH¿ AND ¿PRE-MATURE DETACHMENT¿ WERE CONFIRMED HOWEVER, ¿DIFFICULT PLACEMENT/POSITIONING¿ AND ¿COIL RESISTANCE/STUCK IN CATHETER¿ COULD NOT BE CONFIRMED AS THE DAMAGE TO THE AXIUM PRIME COIL INHIBIT THE TESTING. IT IS LIKELY THAT THE RESISTANCE LED TO THE DIFFICULTY IN POSITIONING OF THE AXIUM PRIME COIL, THE ACTUAL CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. ALL COILS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. PER THE AXIUM PRIME DETACHABLE COIL AND I.D. (INSTANT DETACHER) INSTRUCTIONS FOR USE (IFU): PRECAUTION: ¿DO NOT ADVANCE THE COIL WITH FORCE IF THE COIL BECOMES LODGED WITHIN OR OUTSIDE THE MICROCATHETER. DETERMINE THE CAUSE OF RESISTANCE AND REMOVE THE SYSTEM WHEN NECESSARY.¿ WARNING: "IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD P OSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL." IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE COIL IS EXPECTED TO RETURN FOR EVALUATION. ONCE RECEIVED AND EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT THE RETURN OF THE DEVICE, THE LIKELY CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AFTER SMOOTHLY EXITING THE INTRODUCER SHEATH, WHEN ADVANCING THE COIL THROUGH THE CATHETER AND REPOSITIONING TWICE, THERE WAS RESISTANCE WHEN PUSHING THE COIL AND IT PREMATURELY DETACHED WHILE PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE CATHETER. THE PATIENT WAS RECEIVING TREATMENT FOR A RUPTURED, SACCULAR, LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. MAXIMUM DIAMETER IS 9.8MM AND NECK DIAMETER 4.3MM. THERE WAS MINIMAL VESSEL TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE COIL WAS HYDRATED AS DIRECTED. THE CATHETER WAS FLUSHED AS DIRECTED AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE WAS NOT BENT OR BROKEN AND THERE WAS FRICTION/RESISTANCE DURING DELIVERY. THE COIL WOULD NOT ADVANCE OR PULL BACK, INDICATING THE COIL WAS STUCK AND STRETCHED. THE COIL WAS ATTEMPTED TO BE ADVANCED OUT OF THE CATHETER BY PUSHING IT WITH A GUIDEWIRE, BUT THIS WAS UNSUCCESSFUL. THE COIL WAS PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE CATHETER, PREMATURELY DETACHED. THE HUB OF THE CATHETER WAS CUT OFF AND A 7MM SNARE WAS ADVANCED TO PULL THE COIL AND CATHETER OUT OF THE ANEURYSM TOGETHER. AFTER SUCCESSFUL REMOVAL, THE COIL WAS OBSERVED TO BE STUCK IN THE CATHETER. THERE WERE NO ATTEMPTS MADE TO DETACH THE COIL, PRIOR TO THIS ISSUE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT AND THE PROCEDURE WAS COMPLETED WITH OTHER COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739576 AXIUM PRIME BARE HELIX DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR APB-5-20-HX-SS A456034

    Patients

    Seq Age Sex Outcome Treatment
    1