BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9670709 · Received February 5, 2020

    Report

    Report Number
    2017233-2020-00073
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050006. (B)(4). THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE LIST EMBOLIZATION AS POTENTIAL CLINICAL AND DEVICE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN SELECTED A 27MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT MEASURED TO 10MM WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY. BALLOON SIZING WAS NOT PERFORMED. ADDITIONALLY, THERE WAS A DEFICIENT AORTIC RIM (4MM). THE OCCLUDER WAS SUCCESSFULLY PLACED ON THE SEPTUM. THE CORRECT POSITION WAS CONFIRMED USING TRANSESOPHAGEAL AND FLUOROSCOPIC IMAGING. THE DEVICE WAS ASSESSED, LOCKED AND RELEASED. A FINAL CHECK WITH TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED A RESIDUAL SHUNT ON THE ANTERIOR PART OF THE SEPTUM. THE PHYSICIAN CHOSE TO REMOVE THE DEVICE. WHILE ATTEMPTING TO SNARE THE DEVICE, THE OCCLUDER EMBOLIZED INTO THE RIGHT ATRIUM. AFTER SEVERAL ATTEMPTS, THE OCCLUDER WAS SUCCESSFULLY REMOVED. THE PROCEDURE TOOK APPROXIMATELY 1.5 HOURS AND CONCLUDED WITHOUT DEFECT CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135082 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18414965A

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R