BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 10505216 · Received September 8, 2020

    Report

    Report Number
    2029214-2020-00908
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    September 2, 2020
    Report Date
    December 8, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536021006
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE AXIUM PRIME COIL (MODEL: APB-2-4-HX-ES LOT: B051952) WAS RETURNED FOR ANALYSIS. THE AXIUM PRIME PUSHER WAS FOUND BROKEN BETWEEN THE POSITIVE LOAD INDICATOR AND THE BREAK INDICATOR, WITH THE RELEASE WIRE ALSO BROKEN AT THIS LOCATION. THE PROXIMAL SEGMENT WAS NOT RETURNED SO ANY EVIDENCE OF MECHANICAL DETACHMENT USING AN INSTANT DETACHER COULD NOT BE ASSESSED. THE BREAK INDICATOR WAS FOUND INTACT. THE COIN WAS FOUND PRESENT AND STILL AGAINST THE LUMEN STOP WITH THE SHIELD COIL PRESENT AND INTACT. THE IMPLANT COIL WAS STILL ATTACHED TO THE PUSHER. NO DAMAGES WERE FOUND WITH THE IMPLANT COIL. A DETACHMENT WAS THEN ATTEMPTED BY RETRACTING THE EXPOSED RELEASE WIRE. RESISTANCE WAS ENCOUNTERED WITH THE RELEASE WIRE. THE OUTER JACKET WAS REMOVED, AND DRIED BLOOD WAS OBSERVED UNDER THE OUTER JACKET AND WITHIN THE LUMEN STOP. THE DEVICE WAS PUT INTO AN ULTRASONIC CLEANER TO DISSOLVE THE DRIED BLOOD. THE RELEASE WIRE WAS THEN RETRACTED AGAINST RESISTANCE, AND THE COIN CAME OUT OF THE LUMEN STOP, RELEASING THE IMPLANT COIL. NO OTHER DAMAGES OR ABNORMALITIES WERE OBSERVED. BASED ON THE ANALYSIS PERFORMED, THE CUSTOMER REPORT OF ¿NON-DETACHMENT¿ WAS CONFIRMED AS THE DEVICE WAS RETURNED WITH THE IMPLANT COIL STILL ATTACHED. THERE WAS NO EVIDENCE OF DETACHMENT ATTEMPT USING AN INSTANT DETACHER. THE LIKELY CAUSE OF THE NON-DETACHMENT IS THE DRIED BLOOD BACK FLOWED UP THE OUTER JACKET, COAGULATED AND PREVENTED THE RELEASE WIRE AND COIN TO EXIT OUT OF THE LUMEN STOP. AFTER THE DRIED BLOOD WAS DISSOLVED, RETRACTING THE RELEASE WIRE SUCCESSFULLY DETACHED THE IMPLANT COIL. IT IS UNKNOWN IF THE BLOOD WAS COAGULATED DURING THE PROCEDURE. THE RELEASE WIRE WAS FOUND BROKEN, LIKELY DUE TO ATTEMPTS TO RETRACT THE ACTUATOR INTERFACE DURING DETACHMENT ATTEMPTS AGAINST THE RESISTANCE. NO EVIDENCE OF MANUAL DETACHMENT WAS FOUND AT THE BREAK INDICATOR. THERE WAS NO NON-CONFORMANCE TO SPECIFICATION IDENTIFIED THAT COULD POTENTIALLY CONTRIBUTE TOWARDS THE NON-DETACHMENT. AS THE INSTANT DETACHER INVOLVED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION OF THE INSTANT DETACHER TOWARDS THE NON-DETACHMENT 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

    REFER TO MANUFACTURER REPORT 2029214-2020-00907 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE BATOP WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AN SL-10 MICROCATHETER WAS PLACED, AND THE COIL RECANALIZATION PROCEDURE WAS PERFORMED. TWO AXIUM COILS EXPERIENCED THE SAME NON-DETACHMENT ISSUES. THE COILS WERE ATTEMPTED TO BE DETACHED FIVE TIMES WITH THE INSTANT DETACHER, BUT IT FAILED. ANOTHER INSTANT DETACHER WAS NOT USED, THE MANUAL DETACHMENT METHOD WAS PERFORMED TWICE, BUT THE COILS STILL DID NOT DETACH. IT WAS STATED THERE WERE NO ISSUES WITH THE INSTANT DETACHER, AND THE COILS WERE THEN RETRIEVED WITHOUT FURTHER ACTIONS. DETACHMENT OF COILS WAS SUCCESSFULLY DONE BEFORE AND AFTER THE ISSUE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965287 AXIUM PRIME BRPL HLX DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-2-4-HX-ES B051952 00847536021006

    Patients

    Seq Age Sex Outcome Treatment
    1