BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 14189904 · Received April 22, 2022

    Report

    Report Number
    2017233-2022-02872
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    March 23, 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, TYPE OF INVESTIGATION: ADDED IMDRF CODE B20. H6, COMPONENT CODE: ADDED IMDRF CODE G07001. DESPITE SEVERAL ATTEMPTS MADE, THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THIS EVENT COULD NOT BE OBTAINED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS WAS NOT PERFORMED. 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 CODES 1729, 1730 WITH IMDRF CODES E060102, E060103. H6, HEALTH EFFECT - IMPACT CODE: REPLACED FDA CODE 4648 WITH IMDRF CODE F24. 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 C20. H6, INVESTIGATION CONCLUSIONS: REPLACED FDA CODE 11 WITH IMDRF CODE D15.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2022, A GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FORAMEN OVALE. ON AN UNKNOWN DATE POST IMPLANT, THE PATIENT REPORTEDLY EXPERIENCED ATRIAL FLUTTER OR ATRIAL FIBRILLATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT REPORTEDLY REQUIRED CARDIOVERSION DUE TO ATRIAL FIBRILLATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT'S HEALTH STATUS AND IF THE ARRHYTHMIA HAD RESOLVED. 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
    196721 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention