BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG 4

    MDR report key: 4915104 · Received July 15, 2015

    Report

    Report Number
    2135147-2015-00074
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 24, 2015
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K113658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE 2135147-2015-00073 FOR THE EMBOLIZED 8MM AVP4 (LOT 5003943) THAT WAS PERCUTANEOUSLY RETRIEVED. THE RESULTS OF THIS INVESTIGATION CONFIRMED THE AMPLATZER VASCULAR PLUG 4 MET ALL FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS WHEN ANALYZED AT SJM. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE OCCLUDER MET ALL VISUAL, DIMENSIONAL, AND FUNCTIONAL SPECIFICATIONS AT THE TIME IT WAS MANUFACTURED, PRIOR TO SHIPMENT. THERE WAS NO EVIDENCE TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE OCCLUDER, AND THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    REFERENCE 2135147-2015-00073 FOR THE EMBOLIZED 8MM AVP4 (LOT 5003943) THAT WAS PERCUTANEOUSLY RETRIEVED. (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE TO CLOSE TWO VENTRICULAR SEPTAL DEFECTS (VSD), A TOTAL OF THREE AMPLATZER VASCULAR PLUG 4S (AVP4) WERE USED. INITIALLY, AN 8MM AVP4 WAS IMPLANTED, WITH RESIDUAL FLOW OBSERVED, THEREFORE, A SECOND 8MM AVP4 WAS IMPLANTED IN THE SAME VSD. A SMALLER VSD OBSERVED NEAR THE ORIGINAL DEFECT WAS NOTED AND A 7MM AVP4 IMPLANT WAS ATTEMPTED; HOWEVER, DURING THE ATTEMPTED IMPLANT OF THE 7MM AVP4, IT REPORTEDLY CAUSED ONE OF THE 8MM AVP4S TO EMBOLIZE. THE 7MM AVP4, STILL ATTACHED TO THE DELIVERY WIRE, WAS REMOVED. THE EMBOLIZED 8MM AVP4 WAS SNARED AND REMOVED AND THE IMPLANTED 8MM AVP4 WAS PERCUTANEOUSLY REMOVED. A LARGER, NON-SJM OCCLUDER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459919 AMPLATZER VASCULAR PLUG 4 ARTERIAL EMBOLIZATION DEVICE KRD AGA MEDICAL CORPORATION 9-AVP038-008 5060776

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention