BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO PGLA HLX

    MDR report key: 21403109 · Received February 18, 2025

    Report

    Report Number
    2029214-2025-00447
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 17, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536045040
    PMA / PMN Number
    K090046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PV-16-40-HELIX (B813265); IMPLANT DATE N/A; EXPLANT DATE N/A. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY OPENING MORE COILS AND PROCEDING. THE DAMAGE WAS NOTICED WHEN IT WAS REMOVED FROM THE PACKAGE PULLED FROM THE HOOP. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE¿PUSHWIRE WAS¿SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE¿PACKAGE WAS¿OPENED. COIL WAS NOT USED AND DID NOT ENTER THE BODY.THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT TWO COILS WERE OPENED AND INSPECTED. WHEN THE COILS WERE REMOVED FROM THE PACKAGING HOOP, IT WAS NOTICED THAT THE COILS WERE BROKEN AT THE HYPO TUBE BREAK INDICATOR. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION OF THE GONADAL VEIN. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A 2.4F PROGREAT MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523738 CONCERTO PGLA HLX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 PV-16-40-HELIX B813265 00847536045040

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female