BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9670934 · Received February 5, 2020

    Report

    Report Number
    2017233-2020-00074
    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 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT IN A PATIENT WITH A DEFICIENT AORTIC RIM AND A THIN, FLOPPY POSTERIOR RIM. THE DEFECT WAS BALLOON SIZED TO 15MM. THE PHYSICIAN WAS NOT ABLE TO CAPTURE ENOUGH SEPTAL RIM TO PLACE THE DEVICE AND IT WAS SUBSEQUENTLY REMOVED. A SECOND 32MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED AND ABLE TO BE SUCCESSFULLY DEPLOYED AND LOCKED. THE DEVICE APPEARED TO BE STABLE AS CONFIRMED BY TRANSESOPHAGEAL AND FLUOROSCOPIC IMAGING; HOWEVER, WHEN THE RETRIEVAL CORD WAS REMOVED THE DEVICE EMBOLIZED ANTERIORLY INTO THE RIGHT ATRIUM AND WAS RETRIEVED WITH A SNARE. A THIRD 32MM GORE® CARDIOFORM ASD OCCLUDER WAS ATTEMPTED BUT COULD NOT BE PLACED AND WAS REMOVED. A 16MM CERAFLEX OCCLUDER WAS THEN IMPLANTED WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135510 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 17655088A

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R