BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 13040152 · Received December 18, 2021

    Report

    Report Number
    2017233-2021-02618
    Event Type
    Injury
    Date Received
    December 18, 2021
    Date of Event
    November 13, 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

    H6, COMPONENT CODE: ADDED IMDRF CODE G07001. H6, HEALTH EFFECT - IMPACT CODE: ADDED IMDRF CODE F12. ACCORDING TO THE GORE® CARDIOFORM SEPTAL OCCLUDER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FORAMEN OVALE. FOLLOWING THE IMPLANT, THE PATIENT WAS REPORTED TO HAVE DEVELOPED ATRIAL FIBRILLATION AND WAS ADMITTED TO HOSPITAL, WHERE SHE RECEIVED MEDICATION AND SUBSEQUENTLY SELF-CARDIOVERTED. HOSPITAL DISCHARGE ENSUED AND THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936426 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention