BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 10488616 · Received September 3, 2020

    Report

    Report Number
    2029214-2020-00887
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    July 10, 2020
    Report Date
    September 3, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536032095
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: EQUIPMENT USED: VIS (M-77148), 203CM RULER (M-83360), PIN GAUGE SETS (M-84080 M-84082) THE AXIUM PRIME COIL (MODEL: APB-1-2-HX-ES LOT: A983436) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN A SEALED PLASTIC BIOHAZARD POUCH; WITHIN AN OPENED AXIUM PRIME INNER POUCH; WITHIN A DISPENSER COIL AND WITHIN AN INTRODUCER SHEATH. THE AXIUM PRIME COIL WAS DECONTAMINATED AS PER MANUFACTURER POLICY. THE INTRODUCER SHEATH WAS FOUND INVERTED ON THE PUSHER WITH THE WAVELOCK AT THE DISTAL END. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE INTRODUCER SHEATH. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE AXIUM PRIME PUSHER. THE AXIUM PRIME IMPLANT COIL WAS FOUND STRETCHED, DAMAGED AND BROKEN WITHIN THE INTRODUCER SHEATH WITH THE POLYPROPYLENE FILAMENT ALSO BROKEN. THE DISTAL IMPLANT COIL SEGMENT WAS NOT FOUND WITHIN THE INTRODUCER SHEATH AND WAS NOT RETURNED FOR ANALYSIS. THE AXIUM PRIME WAS ADVANCED OUT OF THE INTRODUCER SHEATH WITH NO RESISTANCE ENCOUNTERED. THE AXIUM PRIME IMPLANT COIL TIP OD (OUTER DIAMETER) COULD NOT BE MEASURED AS IT WAS MISSING. THE INTRODUCER SHEATH ID (INNER DIAMETER) WAS MEASURED AND FOUND TO BE 0.0175¿ (0.4445M M) WHICH IS WITHIN SPECIFICATION: 0.46MM ± 0.02MM). NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL STRETCH¿ WAS CONFIRMED. THE IMPLANT COIL WAS FOUND STRETCHED/DAMAGED/BROKEN. POSSIBLE CAUSES ARE LACK OF HYDRATION BEFORE PROCEDURE, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, TORTUOUS ANATOMY, COIL IS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, USER ADVANCES THE COIL AGAINST RESISTANCE AND INCOMPATIBLE CATHETER. THE CUSTOMER REPORT OF ¿COIL RESISTANCE/STUCK IN SHEATH¿ COULD NOT BE CONFIRMED. THE RETURNED DEVICE HAD NO RESISTANCE WITH THE COIL WITHIN THE INTRODUCER SHEATH. IT IS POSSIBLE THAT RESISTANCE IS NO LONGER ENCOUNTERED AS THE IMPLANT COIL BROKE WHEN ATTEMPTING TO ADVANCE/RETRACT THE DEVICE AGAINST THE REPORTED RESISTANCE. THERE WERE NO REPORTED ISSUES PUSHING THE AXIUM PRIME IMPLANT COIL FROM WITHIN THE INTRODUCER SHEATH DURING PREPARATION PER IFU. THEREFORE, IT IS POSSIBLE THE IMPLANT COIL BECAME DAMAGED WHEN RETRACTING THE IMPLANT COIL FOLLOWING HYDRATION OR DUE TO IMPROPER HUBBING TECHNIQUE (OVER TIGHTENING OF THE RHV/SHEATH NOT FULLY SEATED WITHIN THE HUB) SUBSEQUENTLY CAUSING THE IMPLANT COIL TO BECOME STUCK. ADVANCING THE COIL AGAINST RESISTANCE WOULD RESULT IN DAMAGE TO THE IMPLANT COIL. IN ADDITION, AS THE AXIUM PRIME IMPLANT COIL WAS FOUND TO BE INVERTED WITHIN THE INTRODUCER SHEATH IT IS POSSIBLE THAT RESISTANCE WOULD OCCUR WHEN ATTEMPTING TO PUSH THE IMPLANT COIL OUT FROM THIS PORTION OF THE INTRODUCER SHEATH AS THIS PORTION OF THE INTRODUCER SHEATH IS DESIGNED TO CREATE RESISTANCE WITH THE PUSHWIRE PORTION OF THE AXIUM PRIME COIL. IT IS LIKELY THAT THE CUSTOMER INADVERTENTLY INVERTED THE AXIUM PRIME COIL FOLLOWING HYDRATION OR INSPECTION. PULLING THE AXIUM PRIME COIL THROUGH THE WAVE-LOCK PORTION OF THE INTRODUCER SHEATH WOULD POTENTIALLY CAUSE THE IMPLANT COIL TO BECOME DAMAGED. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE. THE AXIUM PRIME COIL WILL BE RETAINED AS PER MANUFACTURER POLICY. 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 AXIUM COIL WAS STRETCHED AND BECAME STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT MIDDLE ARTERY WITH A MAX DIAMETER OF 1.5MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT AFTER HYDRATION, EMBOLIZATION WAS PERFORMED WITH THE ECHELON-10 MICROCATHETER. THE SURGEON DESCRIBED THE COIL AS BEING FELT HARD AND ABNORMAL DURING THE SURGERY. DURING THE SECOND DELIVERY ATTEMPT, THE COIL WAS NOT PUSHED OUT OF THE SHEATH WHEN PUSHING IT INTO THE MICROCATHETER. ONCE REMOVED, IT WAS FOUND STRETCHED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THE PHYSICIAN REPOSITIONED THE COIL THREE TIMES. FOLLOW-UP RESPONSE RECEIVED REPORTING THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE AS IT WAS HYDRATED DURING PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953698 AXIUM PRIME BRPL HLX DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-1-2-HX-ES A983436 00847536032095

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR