BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 4878264 · Received June 30, 2015

    Report

    Report Number
    2017233-2015-00388
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    June 4, 2015
    Report Date
    August 27, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE DEVICE AND CASE IMAGES WERE RETURNED FOR EVALUATION. THE DEVICE AND IMAGING EVALUATIONS ARE CURRENTLY ONGOING. PMA NUMBER: P050006.

    Additional Manufacturer Narrative · 1

    CASE IMAGES WERE RETURNED FOR EVALUATION. A STATIC DEFECT MEASUREMENT OF APPROXIMATELY 12.7MM WAS ACQUIRED BY THE PERFORMING FACILITY. A BALLOON STOP FLOW MEASUREMENT WAS NOT ACQUIRED. IT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE THAT THE SIZE OF THE DEVICE IMPLANTED BE SELECTED FROM THE MEASUREMENT OF THE DEFECT ACQUIRED FROM STOP FLOW BALLOON TECHNIQUE. AFTER DEPLOYMENT OF THE 30MM GORE SEPTAL OCCLUDER, A PORTION OF THE RIGHT ATRIAL DISC APPEARS TO HAVE MOVEMENT IN LINE WITH THE CARDIAC CYCLE BUT DOES NOT APPEAR TO BE INTERFERING WITH ANY CARDIAC STRUCTURES. THIS MOVEMENT MAY HAVE BEEN CAUSED BY THE HIGH MOBILITY OF THE SEPTUM PRIMUM SEEN IN THE ECHOCARDIOGRAPHIC IMAGING. ANOTHER CONTRIBUTING FACTOR MAY BE WHERE THE SEPTUM PRIMUM ATTACHES AND HOW IT CAUSES THE DEVICE TO SPLAY OVER THE SEPTUM. THE 30MM DEVICE WAS REMOVED AND A 25MM GORE SEPTAL OCCLUDER WAS IMPLANTED. THE 25MM DEVICE ALSO HAD SOME RIGHT DISC MOVEMENT IN LINE WITH THE CARDIAC CYCLE. AGAIN, IT APPEARS TO BE DUE TO THE HIGH MOBILITY OF THE SEPTUM PRIMUM BUT SIGNIFICANTLY LESS THAN THE 30MM DEVICE. THE 25MM DEVICE WAS LEFT IMPLANTED. NO IMAGES WERE PROVIDED OF THE DEVICE EMBOLIZATION, DEVICE RETRIEVAL POST EMBOLIZATION, OR THE IMPLANT OF THE 35MM OCCLUDER FROM ANOTHER MANUFACTURER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED THE BRAND NAME. POPULATED THE PMA/510(K)# FIELD. NOTED THE DEVICE WAS EVALUATED BY THE MANUFACTURER. DEVICE ANALYSIS RESULTS PROVIDED IN THE FIRST FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE OCCLUDER WAS RETURNED TO GORE FOR AN ENGINEERING ANALYSIS. THE INVESTIGATION REVEALED THE SIZE AND SHAPE OF THE OCCLUDER DISCS WERE UNREMARKABLE. BASED ON INSPECTION OF THIS DEVICE, THERE IS NO INDICATION THAT THE REPORTED EVENT WAS DUE TO DESIGN OR MANUFACTURE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT MEASURED TO 12.5MM WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY. THE DEVICE WAS LOCKED AND SEATED; HOWEVER, THE RIGHT ATRIAL DISC DISPLAYED MOBILITY TOWARDS THE ROOF OF THE ATRIUM. THE DEVICE WAS REMOVED AND A 25MM GORE SEPTAL OCCLUDER WAS IMPLANTED WITH NO ADVERSE EFFECTS. THE FOLLOWING DAY, ROUTINE ECHOCARDIOGRAPHY SHOWED THE 25MM GORE SEPTAL OCCLUDER HAD EMBOLIZED INTO THE ABDOMINAL AORTA. THE DEVICE WAS SUCCESSFULLY RETRIEVED WITH A SNARE THROUGH A 12F 30CM SHEATH. THE GROIN ACCESS WAS CLOSED WITH A STITCH. THE NEXT DAY, THE DEFECT WAS BALLOON SIZED AT 12-13MM, AND A 35MM OCCLUDER FROM ANOTHER MANUFACTURER WAS IMPLANTED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421908 GORE® CARDIOFORM SEPTAL OCCLUDER OCCLUDER, TRANSCATHETER SEPTAL MLV W.L. GORE & ASSOCIATES 13356854

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O