BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 8113165 · Received November 28, 2018

    Report

    Report Number
    2029214-2018-00994
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    August 7, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRD
    UDI-DI
    00847536021242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AXIUM PRIME COIL WAS RETURNED FOR EVALUATION WITHOUT THE ECHELON MICROCATHETER AS IT WAS DISCARDED AND WITHOUT THE INTRODUCER SHEATH. THE TACK WELD REPLACEMENT (TWR) CRIMPS WERE FOUND TO BE INTACT. THE PUSHWIRE WAS FOUND TO BE BROKEN INTO TWO SEGMENTS AT APPROXIMATELY 6.0 CM FROM THE PROXIMAL END BUT RETAINED TOGETHER BY THE RELEASE WIRE. THE RELEASE WIRE WAS FOUND TO BE EXPOSED FOR THE LENGTH OF APPROXIMATELY 0.9 CM. THE DISTAL PUSHWIRE SEGMENT WAS MEASURED AND FOUND TO BE APPROXIMATELY 187.3 CM IN LENGTH. UNDER THE MICROSCOPE, THE COIN WAS NOT FOUND TO BE LOCATED AGAINST THE LUMEN STOP, THE COIL SHIELD WAS FOUND TO BE DAMAGED AND THE IMPLANT COIL WAS FOUND TO BE DETACHED AND MISSING. ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL AND NO OTHER ANOMALIES WERE OBSERVED. THE AXIUM PRIME COIL COULD NOT BE USED FOR TESTING WITH AN IN-HOUSE MICROCATHETER DUE TO ITS DAMAGED CONDITION. ALTHOUGH THE CAUSE FOR THE REPORTED RESISTANCE COULD NOT BE DETERMINED, EVIDENCE FOUND DURING ANALYSIS SHOWED A BREAK IN THE PUSHWIRE. IT IS POSSIBLE THAT THE PUSHWIRE BECAME BROKEN AND THE IMPLANT COIL DETACHED DURING RETURN TO MEDTRONIC AS THE CUSTOMER REPORTED NO DAMAGES TO THE AXIUM PRIME COIL AT THE TIME OF THE EVENT. IT COULD NOT BE DETERMINED IF THE AXIUM PRIME COIL MET SPECIFICATIONS DUE TO ITS DAMAGED CONDITION; HOWEVER, 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): DIRECTIONS FOR USE: ¿INSERT THE DISTAL END OF THE INTRODUCER SHEATH THROUGH THE ROTATING HEMOSTATIC VALVE (RHV) AND INTO THE HUB OF THE MICROCATHETER UNTIL THE SHEATH IS FIRMLY SEATED. TIGHTEN THE RHV AROUND THE INTRODUCER SHEATH TO PREVENT BACK FLOW OF BLOOD, BUT NOT SO TIGHT AS TO DAMAGE THE COIL DURING ITS INTRODUCTION INTO THE CATHETER.¿ PRECAUTIONS: ¿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.¿ IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF UNRUPTURED SACCULAR ANEURYSM LOCATED IN P-COMM MEASURING 4 MM X 2 MM, THE MEDTRONIC IMPLANT COIL STUCK AT THE CATHETER HUB. THE IMPLANT COIL WAS REPORTED TO BE ABLE TO BE PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NEW COIL WAS REPLACED WITH ANOTHER COIL AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952912 AXIUM PRIME BRPL 3D DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR APB-3-8-3D-ES A513501 00847536021242

    Patients

    Seq Age Sex Outcome Treatment
    1