BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM FRAMING COIL

    MDR report key: 7540720 · Received May 24, 2018

    Report

    Report Number
    2029214-2018-00452
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 23, 2018
    Report Date
    May 24, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRD
    PMA / PMN Number
    K162704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FRAMING COIL WAS NOT RETURNED FOR ANALYSIS AS IMPLANT COIL REMAINS IMPLANTED IN THE PATIENT AND PUSHWIRE DISCARDED AT THE SITE; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. PER FITZ ROY¿ DETACHABLE COIL AND AXIUM¿ I.D. (INSTANT DETACHER) INSTRUCTIONS FOR USE (IFU): IF FITZ ROY¿ DETACHABLE COIL REPOSITIONING IS NECESSARY, TAKE SPECIAL CARE TO RETRACT COIL UNDER FLUOROSCOPY IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER. IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL. 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 4MM CEREBRAL ANEURYSM, THIS COIL DETACHED PREMATURELY DURING THE RE-POSITIONING INTO THE ANEURYSM. IT WAS REPORTED THAT DURING PROCEDURE, THE PHYSICIAN STARTED IMPLANTING THE AXIUM COIL INTO THE TARGET ANEURYSM AFTER DELIVERING A MICROCATHETER. THE PHYSICIAN REPOSITIONED THE COIL TWICE, AND WHILE MAKING ANOTHER REPOSITIONING ATTEMPT, THE COIL WAS DETACHED PREMATURELY; THE COIL WAS DETACHED WHEN THE PHYSICIAN PULLED THE PUSHER. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHILE PULLING THE PUSHER. ABOUT 3CM OF THE COIL WAS INSIDE THE MICROCATHETER, AND THE REST OF THE COIL WAS OUT OF THE MICROCATHETER. FOR THAT REASON, THE PHYSICIAN PUSHED THE COIL WITH THE PUSHWIRE AND IMPLANTED INTO THE ANEURYSM. THE COIL WAS IMPLANTED SUCCESSFULLY. THE AXIUM WAS PREPARED AS ACCORDING TO THE IFU. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382793 AXIUM FRAMING COIL DEVICE, EMBOLIZATION, VASCULAR KRD COVIDIEN (IRVINE) FC-4-12-3D A583709

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR