BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELIX

    MDR report key: 12566676 · Received October 3, 2021

    Report

    Report Number
    2029214-2021-01232
    Event Type
    Malfunction
    Date Received
    October 3, 2021
    Date of Event
    September 24, 2021
    Report Date
    December 8, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00836462010178
    PMA / PMN Number
    K081465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: AS FOUND CONDITION THE AXIUM COIL WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN AN OPENED AXIUM OUTER CARTON; WITHIN AN OPENED AXIUM INNER POUCH; WITHIN A DISPENSER COIL AND WITHIN AN INTRODUCER SHEATH. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE INTRODUCER SHEATH. BLOOD WAS FOUND WITHIN THE INTRODUCER SHEATH AND ON THE AXIUM DEVICE. THE AXIUM PUSHER WAS FOUND BROKEN DISTAL TO THE BREAK INDICATOR WITH THE RELEASE WIRE ALSO BROKEN AT THIS LOCATION. IT IS LIKELY THAT A MANUAL DETACHMENT WAS ATTEMPTED AT THIS LOCATION. NO OTHER DAMAGES WERE FOUND WITH THE AXIUM PUSHER. THE COIN WAS FOUND STILL AGAINST THE LUMEN STOP. BLOOD WAS FOUND UNDER THE PTFE SHRINK TUBING AND WITHIN THE LUMEN STOP AND RETAINER RING. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE SHIELD COIL. THE IMPLANT COIL WAS FOUND STILL ATTACHED TO THE PUSHER. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE IMPLANT COIL TESTING/ANALYSIS ¿ THE PUSHER WAS THEN BROKEN, AND THE RELEASE WIRE WAS RETRACTED, BUT THE RELEASE WIRE WAS FOUND STUCK. UNDER MAGNIFICATION, THE PTFE SHRINK TUBING WAS REMOVED, AND THE RELEASE WIRE WAS RETRACTED AGAINST RESISTANCE. THE IMPLANT COIL DID NOT DETACH FROM THE PUSHER. THE DRIED BLOOD WAS DISSOLVED, AND THE IMPLANT COIL BECAME DETACHED WITH NO ADDITIONAL ISSUES FOUND. CONCLUSION BASED ON THE CUSTOMER REPORT AND DEVICE ANALYSIS, THE CUSTOMER REPORT OF "NON-DETACHMENT" WAS CONFIRMED. IT IS LIKELY THE CAUSE OF THE NON-DETACHMENT IS THE BLOOD FOUND WITHIN THE LUMEN STOP, RETAINER RING AND UNDER THE JACKET CAUSING THE COIN TO BECOME STUCK WITHIN THE LUMEN STOP AND THE IMPLANT COIL TO BECOME STUCK WITHIN THE RETAINER RING. THE RELEASE WIRE WAS FOUND BROKEN, LIKELY DUE TO ATTEMPTS TO RETRACT AGAINST RESISTANCE CAUSED BY THE DRIED BLOOD. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE, THEREFORE A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED. 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

    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 WAS NOT DETACHED AT THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (RICA) WITH A MAX DIAMETER OF 8.2MM AND A 2.67MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL WAS NOT DETACHED AT THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER THREE TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH WITH A DIFFERENT INSTANT DETACHER. THE MANUAL METHOD OF DETACHMENT WAS ATTEMPTED ONCE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. ANCILLARY DEVICES INCLUDE A NEURON MAX GUIDE CATHETER, A NEURON 6F 070 MICROCATHETER, A EXCELSIOR GUIDEWIRE, AND A TAXCESS 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464294 AXIUM HELIX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 QC-7-30-HELIX A726152 00836462010178

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male