BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO NYLON

    MDR report key: 10273393 · Received July 14, 2020

    Report

    Report Number
    2029214-2020-00690
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    July 10, 2020
    Report Date
    October 15, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536033498
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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

    PRODUCT ANALYSIS: EQUIPMENT USED: VIS (M-77148), MICROSCOPE, 203CM RULER (M-83360), CAMERA (PANASONIC LUMIX DMC-ZS5) THE CONCERTO COIL (CONCERTO MODEL: NV-2-6-HELIX LOT: A925412) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN A RESEALABLE PLASTIC BIOHAZARD POUCH; WITHIN AN OPENED CONCERTO OUTER CARTON; WITHIN AN OPENED CONCERTO INNER POUCH AND WITHIN AN INTRODUCER SHEATH. THE CONCERTO COIL WAS DECONTAMINATED AS PER MANUFACTURER PROTOCOL. THE ACTUATOR INTERFACE, POSITIVE LOAD INDICATOR, COUPLER TUBE, AND BREAK INDICATOR WERE FOUND TO BE INTACT. THERE IS NO EVIDENCE OF ANY DETACHMENT ATTEMPTS BY MECHANICAL OR MANUAL METHODS. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PUSHER. THE IMPLANT COIL WAS FOUND STRETCHED WITHIN THE INTRODUCER SHEATH WITH THE POLYPROPYLENE FILAMENT BROKEN. THE IMPLANT COIL COULD NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH AND WAS RETRACTED OUT PROXIMALLY. THE COIN WAS PRESENT AND AGAINST THE LUMEN STOP. THE SHIELD COIL WAS FOUND INTACT. THE IMPLANT COIL WAS CONFIRMED STILL ATTACHED TO THE PUSHER BUT STRETCHED WITH THE POLYPROPYLENE FILAMENT BROKEN. THE BREAK INDICATOR WAS THEN BROKEN, AND THE RELEASE WIRE WAS RETRACTED, DETACHING THE IMPLANT COIL. NO OTHER DAMAGES OR ANOMALIES WERE FOUND. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER REPORT OF ¿PREMATURE DETACHMENT¿ WAS NOT CONFIRMED AS THE IMPLANT COIL WAS STILL ATTACHED. THERE IS NO MALFUNCTION WITH THE PUSHER OR DETACH ELEMENT THAT WOULD CONTRIBUTE TOWARDS THE PREMATURE DETACHMENT AND IN-HOUSE DETACHMENT ATTEMPT DETACHED THE IMPLANT COIL AS EXPECTED. THE IMPLANT COIL WAS FOUND STRETCHED. POTENTIAL CAUSES FOR THIS FAILURE ARE LACK OF HYDRATION BEFORE PROCEDURE, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, TORTUOUS ANATOMY, COILS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, USER ADVANCES THE COIL AGAINST RESISTANCE, AND INCOMPATIBLE CATHETER. 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 FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED A COMPETITOR'S COIL WAS USED TO COMPLETE THE PROCEDURE, AND A NON-MEDTRONIC CATHETER WAS USED DURING THE PROCEDURE.

    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 THE CONCERTO COIL SEEMED TO DETACH FROM THE PUSHWIRE PRIOR TO ADVANCING THROUGH THE CATHETER DURING THE COIL FLUSHING/PREPARATION PROCESS. THE DEVICES WERE OUTSIDE OF THE PATIENT AT THE TIME OF THE EVENT, AND SO NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY WITH DELIVERY, NO ATTEMPTS TO DETACH THE COIL, NO ROTATION OR REPOSITIONING WAS PERFORMED, AND IT WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE PUSHWIRE. A CONTINUOUS FLUSH WAS NOT ADMINISTERED, BUT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT WITH THE EVENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736655 CONCERTO NYLON DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 NV-2-6-HELIX A925412 00847536033498

    Patients

    Seq Age Sex Outcome Treatment
    1