BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR CX 35 DETACHABLE

    MDR report key: 13014440 · Received December 15, 2021

    Report

    Report Number
    2032493-2021-00500
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 19, 2021
    Report Date
    November 19, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    04987892062933
    PMA / PMN Number
    K151358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS 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 IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE AND DIFFICULT OR DELAYED COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS 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 IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A PRODUCT EVALUATION COULD NOT BE PERFORMED AND THE ALLEGED PRODUCT ISSUE COULD NOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE AND DIFFICULT OR DELAYED COIL DETACHMENT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WOULD NOT DETACH ONCE PLACED IN THE TARGET ARTERY. DURING REMOVAL, THE IMPLANT DETACHED UNEXPECTEDLY AND WAS LEFT ENTIRELY WITHIN THE TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT WOULD NOT DETACH ONCE PLACED IN THE TARGET ARTERY. DURING REMOVAL, THE IMPLANT DETACHED UNEXPECTEDLY AND WAS LEFT ENTIRELY WITHIN THE TREATMENT SITE. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909926 AZUR CX 35 DETACHABLE VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC. MV-AX51019CD 2011105K9 04987892062933

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown