BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM FRAMING COIL

    MDR report key: 7458093 · Received April 25, 2018

    Report

    Report Number
    2029214-2018-00341
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 23, 2018
    Report Date
    April 25, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    PMA / PMN Number
    K162704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AXIUM FRAME COIL HAS NOT BEEN RETURNED FOR EVALUATION AS IT WAS DISCARDED; 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 FITZ ROY¿ DETACHABLE COIL AND AXIUM¿ I.D. (INSTANT DETACHER) INSTRUCTIONS FOR USE (IFU): IF THE COIL DOES NOT DETACH AFTER 3 ATTEMPTS, 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. 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. NEXT STRAIGHTEN THE PUSHER BACK, CONTINUE BENDING AND STRAIGHTENING UNTIL THE PUSHER TUBING OPENS EXPOSING THE RELEASE ELEMENT. 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.¿ MDRS RELATED TO THIS EVENT: 2029214-2018-00340, 2029214-2018-00341. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN INTERNAL CAROTID ARTERY, MEASURING 3.5MMX3MM, THIS COIL WOULD NOT ABLE TO DETACH WITH USING AFTER THREE ATTEMPTS MADE WITH INSTANT DETACHER. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305214 AXIUM FRAMING COIL DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE) FC-3.5-8-3D A407733

    Patients

    Seq Age Sex Outcome Treatment
    1