BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 10132732 · Received June 9, 2020

    Report

    Report Number
    2029214-2020-00532
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 16, 2020
    Report Date
    March 30, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE AXIUM PRIME COIL (MODEL: APB-2-4-3D-ES, LOT: A911401) WAS RETURNED FOR ANALYSIS. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE INTRODUCER SHEATH. THE ACTUATOR INTERFACE WAS FOUND SECURELY ATTACHED TO THE COUPLER TUBE AND THE BREAK INDICATOR WAS FOUND INTACT. NO DETACHMENT ATTEMPTS USING AN INSTANT DETACHER AND BY MANUAL METHODS WERE FOUND AT THESE LOCATIONS. THE PUSHER WAS FOUND KINKED AT THE ACTUATOR INTERFACE. A BREAK WAS FOUND ON THE AXIUM PRIME PUSHER AT ~141.1CM FROM THE PROXIMAL END. THE TWO SEGMENTS WERE RETAINED BY THE INNER LINER AND RELEASE WIRE. THE AXIUM PRIME IMPLANT COIL WAS FOUND DAMAGED WITHIN THE INTRODUCER SHEATH. THE IMPLANT COIL COULD NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH AS IT WAS FOUND TO BE STUCK SO THE IMPLANT COIL WAS RETRACTED OUT PROXIMALLY. THE COIN WAS FOUND STILL AGAINST THE LUMEN STOP. THE SHIELD COIL WAS FOUND INTACT. DRIED BLOOD WAS FOUND UNDER THE OUTER JACKET AND ON THE SHIELD COIL. THE AXIUM PRIME IMPLANT COIL WAS FOUND TO BE STILL ATTACHED TO THE PUSHER. THE IMPLANT COIL WAS FOUND STRETCHED AND DAMAGED WITH THE POLYPROPYLENE FILAMENT INTACT. NO OTHER DAMAGES OR ANOMALIES WERE FOUND. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿PREMATURE DETACHMENT¿ COULD NOT BE CONFIRMED AS THE IMPLANT COIL WAS STILL ATTACHED TO THE PUSHER. THE PUSHER WAS FOUND BROKEN, HOWEVER AS THE INNER LINER DID NOT BREAK, THE RELEASE WIRE DID NOT RETRACT THE COIN OUT OF THE LUMEN STOP AND THE IMPLANT COIL REMAINED STILL ATTACHED. POSSIBLE CAUSES FOR PUSHER KINK/BREAK ARE ADVANCING AGAINST RESISTANCE OR RETURN SHIPPING TO MEDTRONIC AS THE DEVICE WAS RETURNED WITHOUT ITS PROTECTIVE DISPENSER COIL. THE IMPLANT COIL WAS FOUND STRETCHED AND DAMAGED. POSSIBLE CAUSES OF COIL STRETCH/DAMAGE ARE LACK OF HYDRATION BEFORE PROCEDURE, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, TORTUOUS ANATOMY, COIL NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, USER ADVANCES THE COIL AGAINST RESISTANCE OR INCOMPATIBLE CATHETER. AS THE MICRO CATHETER USED DURING THE EVENT WAS NOT RETURNED, AND THE MODEL/LOT NUMBERS WERE NOT REPORTED, COMPATIBILITY AND CONTRIBUTION TOWARDS THE FAILURES COULD NOT BE DETERMINED. 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 AXIUM COIL HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THIS COIL DETACHED PREMATURELY INSIDE THE CATHETER BEFORE REACHING TO THE CORRECT LOCATION. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597225 AXIUM PRIME BRPL 3D DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-2-4-3D-ES A911401

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR