BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL 3D

    MDR report key: 15806659 · Received November 16, 2022

    Report

    Report Number
    2029214-2022-01942
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    August 31, 2022
    Report Date
    January 10, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536021136
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    ANALYSIS OF THE AXIUM PRIME COIL (LOT# A981757) FOUND PER THE AXIUM PRIME COIL IFU (INSTRUCTIONS FOR USE): ¿AXIUM PRIME DETACHABLE COILS SHOULD BE DELIVERED THROUGH A MICROCATHETER WITH A MINIMUM INSIDE DIAMETER OF 0.0165¿-0.017¿ WITH TWO MARKER BANDS¿ THEREFORE, THE EXCELSIOR SL-10 MICRO CATHETER WAS FOUND TO BE COMPATIBLE FOR USE WITH THE AXIUM PRIME COIL. THE AXIUM PRIME IMPLANT COIL WAS RETURNED WITHOUT ITS INTRODUCER SHEATH. THE AXIUM PRIME PUSHWIRE WAS FOUND TO BE BENT AT ~34.0CM FROM DISTAL END. THE AXIUM PRIME IMPLANT COIL WAS FOUND TO BE BROKEN. HOWEVER, THE POLYPROPYLENE STILL INTACT. THE AXIUM PRIME IMPLANT COIL WAS RETURNED FOR ANALYSIS. THE IMPLANT COIL APPEARED TO BE DAMAGED AND STRETCHED. ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL, AND NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/ STUCK IN CATHETER¿ WAS CONFIRMED. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THE AXIUM PRIME IMPLANT COIL WAS FOUND DAMAGED AND THE PUSHWIRE WAS FOUND BENT. IT IS LIKELY THAT THE DAMAGE TO THE AXIUM PRIME IMPLANT COIL AND PUSHWIRE OCCURRED DURING THE ATTEMPT TO PUSH THE COIL THROUGH THE MICRO CATHETER AGAINST THE REPORTED RESISTANCE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THE EXCELSIOR SL-10 MICRO CATHETER WAS FOUND TO BE COMPATIBLE FOR USE WITH THE AXIUM PRIME COIL. INFORMATION REGARDING VESSEL TORTUOSITY AND CONTINUOUS FLUSH DURING DELIVERY NOT PROVIDED, THEREFORE ANY CONTRIBUTING FACTORS COULD NOT BE ASSESSED. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE RESISTANCE ISSUE. 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 HAD RESISTANCE IN THE SHEATH. INDUCTION WAS ATTEMPTED WITH THE CORRESPONDING PRODUCT FROM SL-10 DURING PREOPERATIVE EMBOLIZATION OF A CRANIOTOMY OF A MENINGIOMA BUT RESISTANCE WAS FELT SO IT WAS REMOVED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR AN MENINGIOMA. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830578 AXIUM PRIME BRPL 3D DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-1-4-3D-ES A981757 00847536021136

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female