BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 13863355 · Received March 23, 2022

    Report

    Report Number
    2029214-2022-00460
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 16, 2022
    Report Date
    April 15, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536021211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS:EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-78210), RULER 200CM (M-83361), CAMERA (PANASONIC LUMIX DMC-ZS5) AS FOUND CONDITION: THE AXIUM PRIME COIL WAS RETURNED WITHIN A SHIPPING BOX; WITHIN A PLASTIC BIO-POUCH; AND WITHIN A DISPENSER COIL. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE AXIUM PRIME COIL WAS RETURNED WITHIN THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS FOUND CORRECTLY ASSEMBLED ON THE PUSHWIRE WITH THE WAVELOCK AT THE PROXIMAL END. THE ACTUATOR INTERFACE, POSITIVE LOAD INDICATOR, BREAK INDICATOR, COUPLER TUBE AND ALL CRIMPS ARE PRESENT AND INTACT. THE AXIUM PRIME PUSHWIRE WAS FOUND TO BE BENT AT ~5.3CM FROM PROXIMAL END. THE AXIUM PRIME IMPLANT COIL APPEARED TO BE DAMAGED WITHIN INTRODUCER SHEATH. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS: N/A. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿PUSHWIRE SEPARATION¿ COULD NOT BE CONFIRMED AND THE ROOT CAUSE 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. H6. CODING UPDATED BASED ON ANALYSIS RESULTS. MDR DECISION CORRECTED TO NOT REPORTABLE. ANALYSIS CONFIRMED THAT SEPARATION DID NOT OCCUR AND, THEREFORE, THE EVENT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. NO FURTHER REPORTS WILL BE SUBMITTED UNLESS ADDITIONAL INFORMATION INDICATES A REPORTABLE EVENT. 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 A REPORT THAT AFTER THE GUIDE CATHETER WAS IN PLACE, THE NAVIEN 072-115 WAS DELIVERED, AND THE ECHELON 10 AND GUIDE WIRE WERE CHOSEN, THE COIL WAS DELIVERED. AS THE FIRST COIL WAS BEING DELIVERED, THE DISTAL TIP OF THE PUSH TUBE WAS BROKEN. THEREFORE, IT WAS REPLACED WITH THE SAME SPECIFICATION AND MODEL COIL, AND THE COIL WAS DELIVERED AND DETACHED SMOOTHLY. AFTER ANGIOGRAPHY, THE DENSE EMBOLISM WAS FILLED, THE CATHETER WAS WITHDRAWN AND THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2.5MM NECK DIAM ETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DISTAL END OF THE PUSH TUBE WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863762 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-2.5-6-3D-ES 222381504 00847536021211

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male