BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO NYLON

    MDR report key: 8725570 · Received June 23, 2019

    Report

    Report Number
    2029214-2019-00603
    Event Type
    Malfunction
    Date Received
    June 23, 2019
    Date of Event
    May 30, 2019
    Report Date
    August 25, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10. DEVICE AVAILABLE, RETURN DATE - ADDITIONAL INFORMATION. G4. DATE MANUFACTURER RECEIVED - ADDITIONAL INFORMATION. G7. TYPE OF REPORT - ADDITIONAL INFORMATION. H2. FOLLOW-UP TYPE - ADDITIONAL INFORMATION. H3. DEVICE EVALUATION, DEVICE RETURNED - ADDITIONAL INFORMATION. H6. EVALUATION CODES - ADDITIONAL INFORMATION, DEVICE EVALUATION. H10. ADDITIONAL MANUFACTURER NARRATIVE - ADDITIONAL INFORMATION, DEVICE EVALUATION THE CONCERTO COIL (MODEL: NV-6-20-HELIX LOT: A736872) WAS RETURNED FOR ANALYSIS. THERE WAS NO INSTANT DETACHER, MICROCATHETER, OR ACCESSORIES RETURNED WITH THE DEVICE. THE ACTUATOR WAS SECURELY ATTACHED TO THE COUPLER TUBE. NO DAMAGES WERE FOUND WITH THE ACTUATOR, POSITIVE LOAD INDICATOR, BREAK INDICATOR, COUPLER TUBE OR CRIMPS. THERE IS NO INDICATION THAT ANY MANUAL OR MECHANICAL DETACHMENT ATTEMPTS WERE PERFORMED AT THESE LOCATIONS. THE CONCERTO PUSHWIRE WAS FOUND BENT. THE COIN WAS FOUND TO BE PRESENT AND PUSHED UP AGAINST THE LUMEN STOP; WITH THE SHIELD COIL PRESENT AND INTACT. THE IMPLANT COIL WAS STILL ATTACHED TO THE PUSHWIRE WITH NO DAMAGES FOUND. AN IN-HOUSE INSTANT DETACHER WAS USED TO TEST THE RETURNED CONCERTO COIL. 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 IMPLANT COIL WAS SUCCESSFULLY DETACHED ON THE FIRST ATTEMPT WITHOUT ANY DIFFICULTY. BASED ON THE ANALYSIS PERFORMED, THE CONCERTO COIL WAS CONFIRMED TO HAVE NON-DETACHMENT AS THE PUSHER WAS RETURNED WITH THE IMPLANT COIL STILL ATTACHED, HOWEVER, THE CAUSE OF THE NON-DETACHMENT COULD NOT BE CONFIRMED. 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 · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. CORRESPONDENCE HAS BEEN SENT FOR ADDITIONAL INFORMATION AND DEVICE RETURN. ONCE THE DEVICE HAS BEEN RECEIVED AND INVESTIGATION COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MDRS: 2029214-2019-00599, 2029214-2019-00600, 2029214-2019-00601, 2029214-2019-00602. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT THE PHYSICIAN WAS NOT ABLE TO DETACH 5 MEDTRONIC IMPLANT COILS AFTER PREPARATION ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH NEW COILS. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING SURGERY TO TREAT NEUROVASCULAR ABNORMALITIES. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519116 CONCERTO NYLON DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 NV-6-20-HELIX A736872

    Patients

    Seq Age Sex Outcome Treatment
    1