BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 10329228 · Received July 27, 2020

    Report

    Report Number
    2017233-2020-01055
    Event Type
    Injury
    Date Received
    July 27, 2020
    Date of Event
    April 23, 2017
    Report Date
    July 27, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GORE® CARDIOFORM SEPTAL OCCLUDER INSTRUCTIONS FOR USE LIST NEW ARRHYTHMIA REQUIRING TREATMENT AND THROMBOSIS OR THROMBOEMBOLIC EVENTS RESULTING IN CLINICAL SEQUELAE AS POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS. LITERATURE CITATION: BOVIN A. ET AL.: DOAC AFTER PFO CLOSURE © AM J CASE REP, 2020; 21: E922467.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "DIRECT ORAL ANTICOAGULANTS AFTER PERCUTANEOUS PATENT FORAMEN OVALE (PFO) CLOSURE: A CALL FOR CAUTION" PUBLISHED IN THE AMERICAN JOURNAL OF CASE REPORTS, AVAILABLE ONLINE 20 APRIL 2020. THE ARTICLE REPORTS A (B)(6)-YEAR-OLD WOMAN PRESENTED WITH A CRYPTOGENIC STROKE. ECHOCARDIOGRAPHY REVEALED A PATENT FORAMEN OVALE. THE SEPTAL DEFECT WAS CLOSED PERCUTANEOUSLY USING A 25MM GORE® SEPTAL OCCLUDER WITH OPTIMAL POSITIONING AND WITHOUT IMMEDIATE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON ASPIRIN MONOTHERAPY. THREE WEEKS LATER, SHE PRESENTED WITH ATRIAL FIBRILLATION. A DIRECT ORAL ANTICOAGULANT (DOAC) (RIVAROXABAN 20 MG ONCE DAILY) WAS INITIATED AND ASPIRIN WAS DISCONTINUED. AFTER 4 MONTHS OF FOLLOW-UP, A ROUTINE ECHOCARDIOGRAPHY REVEALED LARGE THROMBI ATTACHED TO BOTH SIDES OF THE OCCLUDER. DOAC WAS DISCONTINUED AND THE ANTITHROMBOTIC TREATMENT WAS SWITCHED TO WARFARIN COMBINED WITH ASPIRIN, AND PARTIAL THROMBUS RESOLUTION WAS SEEN ANOTHER 4 MONTHS LATER. DUE TO INCOMPLETE THROMBUS RESOLUTION AT 1-YEAR FOLLOW-UP, WARFARIN WAS REPLACED BY LOW-MOLECULAR-WEIGHT HEPARIN ADMINISTERED SUBCUTANEOUSLY, RESULTING IN THROMBUS RESOLUTION 3 MONTHS LATER. THE PATIENT IS ASYMPTOMATIC NOW AND DID NOT HAVE THROMBOEMBOLIC COMPLICATIONS IN THE COURSE AFTER DEVICE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794736 GORE CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention