BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3D

    MDR report key: 8780602 · Received July 11, 2019

    Report

    Report Number
    2029214-2019-00727
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 14, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536017610
    PMA / PMN Number
    K081465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10. DEVICE AVAILABLE, RETURN DATE - ADDITIONAL INFORMATION G4. DATE MANUFACTURER RECEIVED - ADDITIONAL INFORMATION G7. TYPE OF REPORT - ADDITIONAL INFORMATION H2. FOLLOW-UP TYPE - ADDITIONAL INFORMATION H3. DEVICE EVALUATION, DEVICE RETURNED - ADDITIONAL INFORMATION H6. EVALUATION CODES - ADDITIONAL INFORMATION, DEVICE EVALUATION H10. ADDITIONAL MANUFACTURER NARRATIVE - ADDITIONAL INFORMATION, DEVICE EVALUATION HE AXIUM COIL (MODEL: QC-3-8-3D LOT: A810990) WAS RETURNED FOR ANALYSIS. WITHIN A DISPENSER COIL AND WITHIN AN INTRODUCER SHEATH. THE RHV USED DURING THIS EVENT WAS NOT RETURNED FOR ANALYSIS. THE AXIUM COIL WAS DECONTAMINATED. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE AXIUM PUSHWIRE. THE INTRODUCER SHEATH WAS FOUND CORRECTLY ASSEMBLED ON THE PUSHER WITH THE WAVELOCK AT THE PROXIMAL END. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE INTRODUCER SHEATH. THE AXIUM IMPLANT COIL WAS FOUND TO BE DAMAGED WITHIN THE INTRODUCER SHEATH. NO BREAKS OR SEPARATIONS WERE FOUND WITH THE IMPLANT COIL. THE AXIUM IMPLANT COIL COULD NOT BE PUSHED OUT FROM WITHIN THE INTRODUCER SHEATH AS RESISTANCE WAS ENCOUNTERED, THEREFORE, COULD NOT BE USED FOR RESISTANCE TESTING WITH AN IN-HOUSE RHV. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL SEPARATION/BREAK¿ WAS NOT CONFIRMED AS THERE WERE NO SEPARATIONS OR BREAKS ON THE IMPLANT COIL. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. 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 COIL COULD NOT BE PUSHED INTO THE Y VALVE TO CONNECT TO THE MICROCATHETER. IT WAS NOTED THERE WAS FRICTION/DIFFICULTY DURING TESTING/DELIVERY. TRIED SEVERAL TIMES WITHOUT RESULT. THEN THE COIL WAS TAKEN OUT OF THE Y VALVE AND PUSHED OUT OF THE PROTECTIVE SHEATH. IT WAS FOUND THAT THE COIL HAD 2 BREAKS IN THE ANTI-UNWOUND WIRE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE, AND THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE COIL WAS HYDRATED AS PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS NOT NOTED TO HAVE BEEN DAMAGED PRIOR TO USE. NEW COIL DEVICES WERE USED TO TREAT THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.8MM AND A NECK DIAMETER OF 3.6MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED/HYDRATED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE SEEN ON THE CATHETER OR PUSHWIRE. TATE PATIENT WAS ULTIMATELY TREATED WITH REPLACEMENT COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575624 AXIUM 3D DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 QC-3-8-3D A810990 00847536017610

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR