BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 11023897 · Received December 16, 2020

    Report

    Report Number
    2029214-2020-01324
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    September 15, 2020
    Report Date
    December 16, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536032125
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AXIUM PRIME COIL (MODEL: APB-1.5-2-HX-ES LOT: B034019) WAS RETURNED FOR ANALYSIS. NO DAMAGES OR ANOMALIES WERE FOUND WITH THE OUTER CARTON AND INNER POUCH WITH ALL SEALS ACCOUNTED FOR BUT BROKEN. THE AXIUM PRIME PUSHER WAS FOUND KINKED AT THE POSITIVE LOAD INDICATOR. THE PUSHER WAS FOUND BROKEN AT THE BREAK INDICATOR WITH THE TWO SEGMENTS RETAINED BY THE RELEASE WIRE. THE COIN WAS RETRACTED OUT OF THE LUMEN STOP WITH THE IMPLANT COIL ALREADY DETACHED AND NOT RETURNED FOR ANALYSIS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER'S REPORT OF "PUSHER KINK/BROKE" WAS CONFIRMED AND THE CUSTOMER REPORT OF "PROD DAMAGED/DEFORMED OUT OF PKG" CANNOT BE RULED OUT. THE AXIUM PRIME PUSHER WAS FOUND KINKED AND BROKEN. AS THE DISPENSER COIL (WITH THE PUSHWIRE CLIP), IMPLANT COIL AND INTRODUCER SHEATH WERE NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION THE DISPENSER COIL, IMPLANT COIL AND INTRODUCER SHEATH TOWARDS THE PUSHER KINK/BREAK AND DAMAGE OUT OF PACKAGING COULD NOT BE DETERMINED. THE IMPLANT COIL DETACHED AS EXPECTED PER DESIGN OF THE PUSHER AND RELEASE WIRE. A FORMAL INVESTIGATION HAS BEEN CONDUCTED REGARDING THIS ISSUE. BASED ON THE FORMAL INVESTIGATION, IT IS POSSIBLE THE DAMAGE OCCURRED DURING PRODUCTION OR UPON OPENING THE PACKAGE AND ATTEMPTING TO REMOVE THE PRODUCT OR AFTER REMOVING IT FROM THE PACKAGE. THE REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THE AXIUM COIL PUSHWIRE WAS BROKEN AND COULD NOT BE USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE THE PACKAGE WAS OPENED, THE PROXIMAL END OF THE PUSHWIRE WAS NOT SECURE IN THE GUIDEWIRE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484939 AXIUM PRIME BRPL HLX DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-1.5-2-HX-ES B034019 00847536032125

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR