BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR CX 35 DETACHABLE

    MDR report key: 17552520 · Received August 15, 2023

    Report

    Report Number
    2032493-2023-00902
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 31, 2023
    Report Date
    July 31, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00812636021041
    PMA / PMN Number
    K151358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H10 (SUMMARY DEVICE EVALUATION). SUMMARY OF DEVICE EVALUATION: THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PUSHER RETURNED WITH NO IMPLANT ATTACHED, AND THE PUSHER HEATER COIL DAMAGED. THE IMPLANT WAS RETURNED STRETCHED AT THE PROXIMAL SECTION AND SEPARATED FROM THE PUSHER. THE INVESTIGATION OF THE PUSHER FOUND THE MONOFILAMENT WITH A MUSHROOM PROFILE AT THE TIP, WHICH INDICATES THAT THE IMPLANT WAS SUCCESSFULLY DETACHED FROM THERMAL ACTIVATION USING A DETACHMENT CONTROLLER. SINCE THE MONOFILAMENT WAS FOUND TO BE THERMALLY DETACHED FROM THE IMPLANT COIL AS INTENDED, THE "FILAMENT" DESCRIBED IN THE REPORTED EVENT MAY HAVE BEEN THE STRETCHED PROXIMAL END OF THE IMPLANT. HOWEVER, THIS INVESTIGATION COULD NOT DETERMINE IF ANY PART OF THE IMPLANT PROTRUDED OUT OF THE HEART WITHOUT MEDICAL IMAGING OF THE PROCEDURE AND THEREFORE, THIS COMPLAINT IS CONSIDERED NON-VERIFIABLE. THE PHYSICAL EVALUATION OF THE DEVICE COULD NOT IDENTIFY THE CONDITIONS OR CIRCUMSTANCES THAT LED TO THE DAMAGE, BUT THE DAMAGE IS CONSISTENT WITH THE DEVICE EXPERIENCING FORCES OVER SPECIFICATION.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ITS EVALUATION IS PENDING; THEREFORE THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES DIFFICULT COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS USED IN A PATIENT TO TREAT RESIDUAL LEAK POST LEFT ATRIAL APPENDAGE OCCLUSION. THERE WERE ALREADY COILS PRESENT FROM THE PREVIOUS LEAK AND THIS WAS THE SECOND PROCEDURE TO TREAT THE LEAK. REPORTEDLY, WHEN THE COIL WAS DETACHED WITH THE USE OF THE DETACHMENT CONTROLLER, THE FILAMENT DID NOT DETACH AND THE TAIL END WAS PROTRUDING OUT OF THE HEART. THE PHYSICIAN USED A SNARE DEVICE AND REMOVED THE COIL OUT OF THE PATIENT WITHOUT ANY HARM. NO OTHER COILS WERE USED AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246110 AZUR CX 35 DETACHABLE DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICROVENTION, INC. 45-750617 0000263212 00812636021041

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention