BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9447684 · Received December 10, 2019

    Report

    Report Number
    2017233-2019-01233
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 13, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    UDI-DI
    00733132636518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # : P050006. (B)(4). THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE LIST DEVICE EMBOLIZATION AS A POTENTIAL CLINICAL AND DEVICE ADVERSE EVENT. FURTHERMORE, THE RECOMMENDED PROCEDURES SECTION STATES: "MEASURE THE SEPTAL DEFECT USING FLUOROSCOPY OR ECHOCARDIOGRAPHY; THE STOP FLOW BALLOON TECHNIQUE IS RECOMMENDED, AS DESCRIBED BELOW: PLACE A CONTRAST FILLED, COMPLIANT BALLOON ACROSS THE DEFECT AND GENTLY INFLATE UNTIL SHUNTING THROUGH THE DEFECT HAS STOPPED. MEASURE THE DIAMETER OF THE DEFECT USING EITHER ECHOCARDIOGRAPHY OR CALIBRATED FLUOROSCOPY." ADDITIONALLY, THE RECOMMENDED PROCEDURES SECTION STATES, "THE SEPTAL TISSUE MARGINS SURROUNDING THE DEFECT MUST BE OF SUFFICIENT SIZE AND INTEGRITY TO PREVENT DISC PROLAPSE THROUGH THE DEFECT AND GORE® CARDIOFORM ASD OCCLUDER EMBOLIZATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT WITH A STATIC MEASUREMENT OF 15MM X 23MM AND AN INFERIOR RIM DEFICIENCY. THE DEFECT WAS NOT BALLOON SIZED. APPROXIMATELY TWO HOURS FOLLOWING THE PROCEDURE, THE DEVICE EMBOLIZED TO THE MAIN PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE. THE DEFECT WAS THEN BALLOON SIZED (NON STOP-FLOW METHOD) TO 36MM, AND A 36MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS IMPLANTED WITH NO ADVERSE EFFECTS. THE PHYSICIAN AND A GORE FIELD SALES ASSOCIATE REVIEWED IMPLANT FLUOROSCOPIC IMAGING AND NOTED THAT IT APPEARED THE DEVICE WAS PROLAPSING ON THE INFERIOR RIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238169 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 16562781A 00733132636518

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention