BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 13362257 · Received January 26, 2022

    Report

    Report Number
    2029214-2022-00104
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    March 15, 2021
    Report Date
    January 26, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    PMA / PMN Number
    K081465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KUNKEL KJ, VILLABLANCA P, ALASWAD K. VEIN GRAFT COIL EMBOLIZATION AND SUCCESSFUL RETRIEVAL WITH A MICRO-SNARE. CARDIOVASCULAR REVASC ULARIZATION MEDICINE: INCLUDING MOLECULAR INTERVENTIONS. 2021;28S:78-80. DOI:10.1016/J.CARREV.2021.03.014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    KUNKEL KJ, VILLABLANCA P, ALASWAD K. VEIN GRAFT COIL EMBOLIZATION AND SUCCESSFUL RETRIEVAL WITH A MICRO-SNARE. CARDIOVASCULAR REVASC ULARIZATION MEDICINE: INCLUDING MOLECULAR INTERVENTIONS. 2021;28S:78-80. DOI:10.1016/J.CARREV.2021.03.014. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH AN AXIUM COIL. THE PURPOSE OF THIS ARTICLE WAS TO PRESENT THE CASE OF COIL RETRIEVAL FOR A PATIENT UNDERGOING VEIN GRAFT EMBOLIZATION. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: TWO AXIUM PRIME COILS WERE RELEASED INTO THE VEIN GRAFT. INITIAL FOLLOW UP ANGIOGRAPHY DEMONSTRATED NO FLOW IN THE DIAGONAL BRANCH. A MORE FORCEFUL INJECTION WAS THEN PERFORMED TO OPACIFY THE CORONARY VASCULATURE. DUE TO THE HYDROSTATIC FORCE OF CONTRAST INJECTION, THE TWO VASCULAR COILS WERE DISPLACED TOWARD THE AORTOGRAFT ANASTOMOSIS AND ULTIMATELY EMBOLIZED INTO THE TWO REMAINING BRANCHES OF THE TRIFURCATING GRAFT TO THE LEFT ANTERIOR DESCENDING AND OBTUSE MARGINAL BRANCH. THE COILS WERE SUCCESSFULLY WITHDRAWN WITH A GOOSENECK MICRO-SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592136 AXIUM PRIME BRPL HLX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-4-6-HX-SS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention