BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 15712499 · Received November 1, 2022

    Report

    Report Number
    2029214-2022-01860
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 18, 2022
    Report Date
    December 20, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536031906
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE AXIUM COIL (LOT# B212606) FOUND THE AXIUM PRIME PUSHER ACTUATOR INTERFACE (AI) AND HYPOTUBE BREAK INDICATOR (HBI) INTACT. MULTIPLE KINKS WERE FOUND WITHIN THE DISTAL ~31.0CM OF THE AXIUM PRIME PUSHER. THE PUSHER SHIELD COIL WAS FOUND STRETCHED AND THE IMPLANT COIL WAS FOUND DETACHED. THE DETACHED IMPLANT COIL WAS NOT RETURNED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿PREMATURE DETACHMENT¿ REPORT WAS CONFIRMED. POSSIBLE CAUSES OF ¿PREMATURE DETACHMENT¿ INCLUDE TORTUOUS ANATOMY, COIL IS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHER ROTATION, USER ADVANCES THE COIL AGAINST RESISTANCE, OR DAMAGED PUSHER. THE PATIENT¿S VESSEL TORTUOSITY WAS ¿MODERATE¿, NO REPOSITIONING WAS PERFORMED WITH THE AXIUM PRIME COIL, THE PUSHER WAS NOT ROTATED DURING DELIVERY, AND NO FRICTION OR DIFFICULTY WAS REPORTED DURING DELIVERY. THEREFORE, TORTUOUS ANATOMY, COIL IS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHER ROTATION, AND USER ADVANCES THE COIL AGAINST RESISTANCE WERE RULED OUT AS POTENTIAL CAUSES. IN THIS EVENT, THE DAMAGES FOUND WITH THE AXIUM PRIME PUSHER (KINKING) CONTRIBUTED TO THE EVENT. THE PUSHER CAN BECOME DAMAGED IF ADVANCED AGAINST RESISTANCE. HOWEVER, THE CAUSE FOR THE DAMAGE 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 · 0

    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY IN THE CATHETER. THE COIL IS PRE-DETACHED AND MIGRATED IN THE MICROCATHETER. REMOVE THE CATHETER, REMOVE THE COIL, AND USE ANOTHER COIL. THE COIL IS PRE-DETACHED AND MIGRATED IN THE MICROCATHETER. REMOVE THE CATHETER, REMOVE THE COIL, AND USE ANOTHER COIL. SURGICAL OR MEDICAL INTERVENTION WAS NOT REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THEY DID NOT ROTATE THE DELIVERY PUSHER DURING INJECTION. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT A COM A LOCATION. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOM OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: FUBUKI 8F GUIDE CATHETER, HEADWAY17 MICROCATHETER, SYNCHRO14 GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058784 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-2.5-4-3D-ES B212606 00847536031906

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male