BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARE AXIUM 3D COIL

    MDR report key: 8725580 · Received June 23, 2019

    Report

    Report Number
    2029214-2019-00604
    Event Type
    Malfunction
    Date Received
    June 23, 2019
    Date of Event
    May 31, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    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 FOR EVALUATION - ADDITIONAL INFORMATION. G4. DATE MFR REC ¿ ADDITIONAL INFORMATION. H2: TYPE OF FOLLOW UP - DEVICE EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER- ADDITIONAL INFORMATION. H6: CODES UPDATED THE DEVICE WAS RETURNED FOR EVALUATION AND THE CLINICAL OBSERVATION WAS CONFIRMED. AS RECEIVED, THE AXIUM IMPLANT COIL RETURNED WITHIN INTRODUCER SHEATH, FOUND STRETCHED AND DAMAGED AND BROKEN OFF FROM THE DETACH ELEMENT WITH THE POLYPROPYLENE FILAMENT ALSO BROKEN . THE ACTUATOR INTERFACE WAS SECURELY ATTACHED TO THE COUPLER TUBE. THE ACTUATOR INTERFACE, POSITIVE LOAD INDICATOR, BREAK INDICATOR, COUPLER TUBE AND ALL CRIMPS ARE PRESENT AND INTACT EXCEPT FOR A SLIGHT BEND FOUND AT THE POSITIVE LOAD INDICATOR. NO BENDS OR KINKS WERE FOUND ON THE REST OF THE AXIUM PUSHWIRE. THE COIN WAS FOUND PRESENT AND PUSHED UP AGAINST THE LUMEN STOP. THE SHIELD COIL WAS FOUND INTACT WITH THE DETACH ELEMENT STILL ATTACHED TO THE PUSHWIRE. THE IMPLANT COIL COULD NOT BE FLUSHED OUT OF THE INTRODUCER SHEATH AS IT APPEARS TO BE STUCK AND THE INTRODUCER SHEATH WAS CUT TO GAIN ACCESS TO THE IMPLANT COIL. THE IMPLANT COIL WAS FOUND STRETCHED AND DAMAGED. BASED ON THE DEVICE EVALUATION AND REPORTED INFORMATION, IT IS LIKELY CAUSE OF THE SEPARATION OF THE COIL IS THE REPEATED PUSHING AND PULLING OF THE AXIUM IMPLANT COIL AGAINST THE RESISTANCE REPORTED BY THE PHYSICIAN. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND IRREGULARITIES DURING MANUFACTURE. 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 INVOLVED IN THE REPORTED EVENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. CORRESPONDENCE HAS BEEN SENT OUT FOR THE DEVICE. ONCE THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT RESISTANCE WAS FELT WITH THE IMPLANT COIL AS IT WAS BEING PUSHED THROUGH THE INTRODUCER SHEATH AND IT DETACHED PREMATURELY. THE PATIENT UNDERWENT COILING TREATMENT FOR A SMALL UNRUPTURED SACCULAR LEFT ANEURYSM, MEASURING 3MMX2MM. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519146 BARE AXIUM 3D COIL DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 QC-3-6-3D A810381

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR