BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 11222409 · Received January 25, 2021

    Report

    Report Number
    2029214-2021-00092
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 6, 2021
    Report Date
    April 14, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536031814
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H3: THE AXIUM PRIME COIL APPEARED TO BE DETACHED FROM THE PUSHWIRE. THERE WAS NO IMPLANT COIL OR CATHETER RETURNED WITH THE PUSHER. THE AI AND COUPLER TUBING WERE NOT PRESENT AND MISSING; IT APPEARED THAT MECHANICAL DETACHMENT WAS ATTEMPTED. IN ADDITION, THE PUSHER APPEARED TO BE BROKEN AT THE BREAK INDICATOR (MANUAL DETACHMENT LOCATION) WITH THE RELEASE WIRE PULLING BACK; IT APPEARED THAT THE MANUAL DETACHMENT WAS ALSO ATTEMPTED AT THIS LOCATION. THE COIN WAS NOT PRESENT AGAINST THE LUMEN STOP AS IT WAS PULLING BACK. THE COIL SHIELD WAS PRESENT; BUT STRETCHED. UNDER THE MICROSCOPE, THE OUTER JACKET WAS THEN REMOVED TO GAIN ACCESS THE COIN. THE COIN WAS MEASURED IN 3 LOCATIONS AND WAS FOUND TO BE WITHIN SPECIFICATIONS. MEASURED 0.079MM @ 0.063MM; MEASURED 0.087MM @ 0.127MM; MEASURED 0.099MM @ 0.275MM. THE INNER DIAMETER OF THE LUMEN STOP AND THE INNER DIAMETER OF THE RETAINER RING WERE FOUND TO BE VISUALLY ACCEPTABLE. THE LUMEN STOP INNER DIAMETER (ID) WAS MEASURED TO BE 0.00260¿ AND FOUND TO BE WITHIN SPECIFICATION (0.00220" MINIMUM - 0. 0029" MAXIMUM). THE RETAINER RING INNER DIAMETER (ID) WAS MEASURED TO BE 0.00463¿AND FOUND TO BE WITHIN SPECIFICATION (0.00455"+/- 0.00010"). ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL. NO OTHER ANOMALIES WERE OBSERVED. NO OTHER AN OMALIES WERE OBSERVED. BASED ON THE ANALYSIS PERFORMED, THE AXIUM PRIME COIL WAS NOT CONFIRMED TO HAVE "NON-DETACHMENT" ISSUE AS THE PUSHWIRE WAS RETURNED WITH THE IMPLANT COIL ALREADY DETACHED. BASED ON THE RETURNED DEVICE, THERE WAS EVIDENCE OF MECHANICAL AND MANUAL DETACHMENT ATTEMPTS TO DETACH THE COIL. THE PUSHER WAS ALSO FOUND TO BE BROKEN AT THE MANUAL DETACHMENT LOCATION AND RETAINED BY THE RELEASE WIRE; WITH THE COIN PULLED BACK FROM THE LUMEN STOP. THE PULLING BACK OF THE COIN FROM THE LUMEN STOP MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE IMPLANT COIL FROM THE PUSHWIRE. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE NON-DETACHMENT ISSUE. SINCE THE IMPLANT COIL, AI AND COUPLER TUBING WERE NOT RETURNED, ANY CONTRIBUTION OF THE IMPLANT COIL, AI, AND COUPLER TUBING TO THE NON-DETACHMENT ISSUE COULD NOT BE DETERMINED. THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. 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

    ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ISSUES REPORTED THAT MAY HAVE RESULTED IN THE DAMAGE FOUND TO THE COIL. TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND TWO ATTEMPTS VIA THE MANUAL DETACHMENT METHOD. AFTER REMOVAL, THERE WAS NO DAMAGE REPORTEDLY OBSERVED TO THE PUSHWIRE. THE INSTANT DETACHER LOT #: A873975; MICROCATHETER MODEL: 145-5091-150; LOT #: B083780.

    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 AFTER THE MICROCATHETER WAS IN PLACE, THE AXIUM COIL WAS SELECTED TO FORM THE HOOP, BUT THE TAIL END OF THE COIL WAS STRETCHED. THE COIL WAS WITHDRAWN, AND A REPLACEMENT COIL WAS USED IN THE PROCEDURE. ANOTHER AXIUM COIL WAS USED IN THE PROCEDURE, AND IT COULD NOT BE DETACHED, AND A REPLACEMENT COIL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 5.3 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119711 AXIUM PRIME BRPL 3D DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-1-2-3D-ES B055437 00847536031814

    Patients

    Seq Age Sex Outcome Treatment
    1