BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR VASCULAR PLUG 8

    MDR report key: 13939899 · Received March 29, 2022

    Report

    Report Number
    2032493-2022-00118
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 4, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    UDI-DI
    00842429101636
    PMA / PMN Number
    K191680
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCE 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 REMAINS IMPLANTED IN THE PATIENT AND PROCEDURE IMAGES WERE NOT PROVIDED; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES IMPLANT MIGRATION AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE STATEMENT PROVIDED IN SECTION B5 IN INITIAL MDR INCORRECTLY INDICATED (THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U.S. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA). THE AZUR VASCULAR PLUG DEVICE IS AN APPROVED DEVICE IN THE US UNDER 510(K) NUMBER: K191680 AS WAS INDICATED IN SECTION G4 IN INITIAL MDR. THEREFORE, THE SIMILAR DEVICE REPORTING CATEGORY IS NO APPLICABLE IN THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE THE AZUR VASCULAR PLUG WAS PLACED IN THE PROXIMAL SPLENIC ARTERY JUST DISTAL TO A 3CM ANEURYSM. AFTER ABOUT 5 MINUTES OF ELAPSED TIME, THE PLUG MIGRATED FORWARD TO THE DISTAL SPLENIC ARTERY. ADDITIONAL COILS WERE PLACED IN THE PROXIMAL SPLENIC ARTERY AND OCCLUSION WAS ACHIEVED. THE SPLENIC ARTERY MEASURED 7MM ON CTA. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT. THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE U.S. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2900185 AZUR VASCULAR PLUG 8 VASCULAR EMBOLIZATION DEVICE KRD MICROVENTION, INC. 45-181000 0000090106 00842429101636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention