BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 13059689 · Received December 22, 2021

    Report

    Report Number
    2017233-2021-02628
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 20, 2021
    Report Date
    January 30, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    H6, COMPONENT CODE: ADDED IMDRF CODE G07001. H6, HEALTH EFFECT - IMPACT CODE: ADDED IMDRF CODE F12. ACCORDING TO THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA, SUCH AS ATRIAL FIBRILLATION OR FLUTTER, REQUIRING TREATMENT. WITH THE INFORMATION REPORTED TO GORE THIS INVESTIGATION IS CONSIDERED COMPLETE, THE CAUSE OF THE COMPLAINT WAS UNABLE TO BE DETERMINED. H6, HEALTH EFFECT - CLINICAL CODE: REPLACED FDA CODE 1729 WITH IMDRF CODE E060102. H6, HEALTH EFFECT - IMPACT CODE: REPLACED FDA CODE 4644 WITH IMDRF CODE F2303. H6, MEDICAL DEVICE PROBLEM CODE: REPLACED FDA CODE 2993 WITH IMDRF CODE A24. H6, TYPE OF INVESTIGATION: REPLACED FDA CODES 3331, 4111, 4117, WITH IMDRF CODES B14, B13, B20. H6, INVESTIGATION FINDINGS: REPLACED FDA CODE 213 WITH IMDRF CODE C19. H6, INVESTIGATION CONCLUSIONS: REPLACED FDA CODE 11 WITH IMDRF CODE D15.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE A 44MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. FOLLOWING THE IMPLANT, THE PATIENT WAS EMERGENTLY ADMITTED TO HOSPITAL WITH PALPITATIONS AND SHORTNESS OF BREATH WITH AN ELECTROCARDIOGRAM CONFIRMING ATRIAL FIBRILLATION. HOWEVER, THE PATIENT SELF-CONVERTED AND A CHEST X-RAY FOUND THE DEVICE HAD NOT CHANGED ITS POSITION. THE PATIENT COMMENCED ON BETA BLOCKER MEDICATION AND NO FURTHER SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963727 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention