BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO NYLON

    MDR report key: 21913275 · Received April 25, 2025

    Report

    Report Number
    2029214-2025-01071
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 25, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536044883
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE CONCERTO IMPLANT COILS WERE BOTH RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN INDIVIDUAL OPENED CONCERTO IMPLANT COIL OUTER CARTONS, AND WITHIN INDIVIDUAL RESEALABLE BIOHAZARD PLASTIC BAGS. DAMAGE LOCATION DETAILS: THE CONCERTO IMPLANT COIL WAS RETURNED WITHOUT THE INTRODUCER SHEATH. THE PUSHWIRE WAS FOUND TO BE BENT AT ~115.9CM, KINKED AT ~143.9CM, AND BROKEN WITH THE RELEASE WIRE VISIBLE (NOT PULLED) AT ~144.8CM FROM THE PROXIMAL END. THE CONCERTO IMPLANT COIL WAS RETURNED STRETCHED AND DAMAGED. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): THE CONCERTO IMPLANT COIL TIP OD (OUTER DIAMETER) WAS MEASURED TO BE .0109¿, WHICH WAS FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION .0112¿ +.0010¿/-.002¿). THE INTRODUCER SHEATH WAS NOT RETURNED FOR FURTHER ASSESSMENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING TWO CONCERTO COILS THAT HAD RESISTANCE/WERE STUCK IN THE SHEATH. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COILS COULD NOT BE INTRODUCED IN THE MICROCATHETER AND IT WAS NOTED THAT BOTH COILS HAD THE SAME ISSUE OF COIL RESISTANCE/STUCK IN SHEATH. BOTH OF THE COMPLAINT COILS WERE REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826479 CONCERTO NYLON DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 NV-2-8-HELIX 229116192 00847536044883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown