BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO NYLON

    MDR report key: 11227544 · Received January 25, 2021

    Report

    Report Number
    2029214-2021-00095
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    January 20, 2021
    Report Date
    February 15, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    PMA / PMN Number
    K090046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: PATIENT CODE E2008, HEALTH IMPACT CODE F1901, DEVICE CODES A010402 AND A040611, METHOD CODE B17, RESULT CODE C20, AND CONCLUSION CODE D14 NO LONGER APPLY TO THIS EVENT. H10: REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED A WAY THAT COULD LEAD TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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 INDICATED THE 3X8 COIL DID NOT MIGRATE. IT WAS A MISINTERPRETATION OF THE X-RAY. THE COIL WAS STILL IN PLACE AND LOOKED GREAT.

    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 ONE CONCERTO COIL HAD RESISTANCE IN THE MICROCATHETER, AND ANOTHER CONCERTO COIL MIGRATED AFTER DEPLOYMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR COLLATERALS. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT IN THE MIDDLE OF A SEVERAL COIL PROCEDURE IT WAS HARD TO ADVANCE THE COIL PUSHERWIRE IN THE PROXIMAL SEGMENT OF THE CATHETER. THE MICROCATHETER WAS FLUSHED AND THE DOCTOR WAS HOLDING THE INTRODUCER INTO THE HUB AND THE FELLOW WAS ADVANCING THE PUSHER WIRE. THEY SWITCHED POSITIONS AND THE SAME ISSUE OCCURRED WITH THE COIL BACKING OUT OF THE HUB. THEY RESHEATHED AND FLUSHED THE LANTERN CATHETER AND TRIED AGAIN, BUT THE ISSUE PERSISTED. THEY PULLED THE INTRODUCER SHEATH BACK TO TRY TO ADVANCE FROM THE HUB, BUT THE PUSHER WIRE WASN¿T THICK ENOUGH/FAR ENOUGH IN TO BE ABLE TO ADVANCE, SO A DIFFERENT COIL WAS USED. THERE WAS NO DAMAGE NOTED TO THE COIL OR CATHETER. THE DAY AFTER THE PROCEDURE WAS COMPLETED IT WAS REPORTED THAT ONE OF THE CONCERTO COILS USED HAD MIGRATED. THE COIL WAS UNRAVELING AND STICKING OUT INTO THE SUBCLAVIAN FROM THE LEFT INTERNAL MAMMARY, WHERE IT WAS PLACED. THE COIL HAD BEEN IMPLANTED AT THE INTENDED LOCATION. THE DOCTOR WAS PLANNING ON SNARING IT OUT. THE DOCTOR BELIEVED THE MIGRATION WAS CAUSED BY THE VESSEL POSSIBLY BEING LARGER BUT HAD CHOSEN A SMALLER COIL DUE TO ITS LENGTH AND THE LACK OF SPACE. THE PATIENT STATUS WAS SAID TO BE ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE DEVICES WERE NOT PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AS THEY DIDN¿T USE A BACKFLUSH. ANCILLARY DEVICES INCLUDE A PENUMBRA LANTERN 45-DEGREE MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122766 CONCERTO NYLON DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 NV-3-8-HELIX NOT-REP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention