BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9740631 · Received February 21, 2020

    Report

    Report Number
    2017233-2020-00117
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 3, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P050006. THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE STATES: ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA REQUIRING TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE A 44MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE WAS LOCKED AND IN PLACE; HOWEVER, THE DEVICE SHIFTED AND WAS REMOVED AS THE PHYSICIAN DID NOT LIKE THE POSITION. A SECOND 44MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED; HOWEVER, DURING IMPLANT THE PATIENT DEVELOPED AN AV DISSOCIATION ARRHYTHMIA. THE PATIENT WAS TREATED WITH TWO ROUNDS OF ATROPINE WITH NO RESPONSE. THE PATIENT RETURNED TO A REGULAR SINUS RHYTHM WITH A PACER, HOWEVER, THE PHYSICIAN DID NOT WANT TO CONTINUE WITH THE PROCEDURE. THE PATIENT LEFT THE CATHETERIZATION LAB AND SURGICAL CLOSURE WILL BE DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204165 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention