BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 13518189 · Received February 11, 2022

    Report

    Report Number
    2017233-2022-02736
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    November 23, 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

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION.

    Additional Manufacturer Narrative · 0

    H6, COMPONENT CODE: ADDED IMDRF CODE G07001. H6, TYPE OF INVESTIGATION: ADDED IMDRF CODE B20. H6, INVESTIGATION FINDINGS: ADDED IMDRF CODE C19. H6, HEALTH EFFECT - IMPACT CODE: ADDED IMDRF CODE F12. 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 CODES 3331, 4111, WITH IMDRF CODES B14, B13. 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 ON (B)(6) 2021, A GORE A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FORAMEN OVALE POST CRYPTOGENIC STROKE. ON (B)(6) 2021, THE PATIENT RETURNED WITH TRANSIENT ATRIAL FLUTTER AND WAS PRESCRIBED BETA BLOCKER AND ANTICOAGULANT MEDICATIONS. THE FLUTTER HAD REPORTEDLY NOT RESOLVED ON (B)(6) 2022 AND A FURTHER FOLLOW-UP VISIT HAD BEEN SCHEDULED.

    Description of Event or Problem · 0

    THE FLUTTER HAD REPORTEDLY NOT RESOLVED ON (B)(6) 2022 AND A FURTHER FOLLOW-UP VISIT HAD BEEN SCHEDULED. HOWEVER, DESPITE MULTIPLE ATTEMPTS, 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
    1081907 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention