BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO NYLON

    MDR report key: 10155028 · Received June 15, 2020

    Report

    Report Number
    2029214-2020-00557
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    April 27, 2020
    Report Date
    September 17, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536013346
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE CONCERTO COIL (MODEL: NV-2-8-HELIX , LOT: A820223) WAS RETURNED FOR ANALYSIS. THE INSTANT DETACHER USED IN THE EVENT WAS NOT RETURNED. THE ACTUATOR INTERFACE (AI) APPEARS TO BE INTACT AND NOT LOOSE. THE CONCERTO PUSHER WAS FOUND IN ONE PIECE. THE TACK WELD REPLACEMENT (TWR) CRIMPS AND THE PUSHER DISTAL TO THE BREAK INDICATOR AT THE MANUAL LOCATION (VIA HYPOTUBE) WERE FOUND TO BE INTACT. THE CONCERTO COIL WAS RETURNED WITHIN ITS INTRODUCER SHEATH. THE IMPLANT COIL APPEARED TO BE STILL ATTACHED TO THE PUSHWIRE WITHIN THE INTRODUCER SHEATH; HOWEVER, THE IMPLANT COIL WAS FOUND DAMAGED. THE CONCERTO COIL WAS UNABLE TO BE PUSHED OUT FROM THE INTRODUCER SHEATH AS RESISTANCE WAS ENCOUNTERED. THEREFORE, THE CONCERTO COIL WAS PULLED OUT PROXIMALLY FROM WITHIN THE INTRODUCER SHEATH. NO BENDS OR KINKS WERE FOUND WITH THE PUSHWIRE. UNDER THE MICROSCOPE, THE COIN WAS FOUND TO BE LOCATED AGAINST THE LUMEN STOP, THE SHIELD COIL WAS FOUND TO BE PRESENT, AND THE IMPLANT COIL WAS STILL ATTACHED TO THE PUSHWIRE. AN IN-HOUSE INSTANT DETACHER (MODEL: ID-1, LOT: 9450155) WAS THEN SELECTED FOR DETACHMENT TESTING. NO DIFFICULTY WAS EXPERIENCED INSERTING THE PUSHWIRE INTO THE INSTANT DETACHER, AND THE LOAD INDICATOR WAS NOT VISIBLE WHEN THE PUSHWIRE WAS FULLY SEATED IN THE INSTANT DETACHER CAP. THE IN-HOUSE INSTANT DETACHER WAS THEN USED TO SUCCESSFULLY DETACH THE CONCERTO COIL ON THE FIRST ATTEMPT WITHOUT DIFFICULTY. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿NON-DETACHMENT¿ WAS CONFIRMED. THE CONCERTO COIL WAS RETURNED FOR EVALUATION WITH THE IMPLANT COIL STILL ATTACHED TO THE PUSHWIRE. THE INSTANT DETACHER USED IN THE EVENT WAS NOT RETURNED. THEREFORE, ANALYSIS COULD NOT BE PERFORMED AND CONFORMANCE TO SPECIFICATION COULD NOT BE ASSESSED. THERE HAS BEEN NO VISUAL ATTEMPT TO DETACH THE IMPLANT UTILIZING EITHER THE INSTANT DETACHER NOR THE MANUAL DETACHMENT METHOD. THERE IS NO EVIDENCE THAT THE INSTANT DETACHER USED BY THE PHYSICIAN ENGAGED OR PULLED ON THE ACTUATOR INTERFACE. THEREFORE, THE CAUSE 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.

    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

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PROCEDURE WAS COMPLETED WELL USING THE SAME PRODUCTS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

    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 INFORMATION THAT THE CONCERTO COIL COULD NOT BE DETACHED INSIDE IN THE VESSEL. THE PROCEDURE WAS COMPLETED WELL WITH ANOTHER MEDTRONIC PRODUCT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615557 CONCERTO NYLON DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 NV-2-8-HELIX A820223 00847536013346

    Patients

    Seq Age Sex Outcome Treatment
    1