BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 14189914 · Received April 22, 2022

    Report

    Report Number
    2017233-2022-02868
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    March 11, 2022
    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 GORE® CARDIOFORM SEPTAL OCCLUDER REMAINS IMPLANTED IN THE PATIENT AND WILL THEREFORE NOT BE RETURNED.

    Additional Manufacturer Narrative · 0

    H6, HEALTH EFFECT - IMPACT CODE: ADDED IMDRF CODE F12. H6, COMPONENT CODE: ADDED IMDRF CODE G07001. H6, TYPE OF INVESTIGATION: ADDED IMDRF CODES B13, B20. CODE C19 - THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. 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 1730 WITH IMDRF CODE E060103. 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 CODE 3331 WITH IMDRF CODE B14. H6, INVESTIGATION FINDINGS: REPLACED FDA CODE 3233 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 THAT A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2022. SUBSEQUENTLY, ATRIAL FLUTTER WAS DIAGNOSED ON (B)(6) 2022 AND THE PATIENT WAS PLACED ON MEDICAL THERAPY, THE PATIENT WAS REPORTED TO HAVE BEEN SCHEDULED FOR CARDIOVERSION.

    Description of Event or Problem · 0

    THE PATIENT WAS REPORTED TO HAVE BEEN SCHEDULED FOR CARDIOVERSION. HOWEVER, DESPITE MULTIPLE ATTEMPTS MADE, ADDITIONAL INFORMATION ON THE PATIENT'S HEALTH STATUS COULD NOT BE OBTAINED. ON JUNE 27, 2022 IT WAS REPORTED TO GORE THAT NO FURTHER INFORMATION ON THIS PATIENT WAS AVAILABLE. THE STATUS OF THE PATIENT IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196731 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention