BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9699316 · Received February 12, 2020

    Report

    Report Number
    2017233-2020-00091
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 16, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    UDI-DI
    00733132636501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050006. THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE LIST THROMBUS AS POTENTIAL CLINICAL AND DEVICE ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN IMPLANTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT ON (B)(6) 2019. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2019, ECHOCARDIOGRAPHY SHOWED THE DEVICE APPEARED NORMAL. AT THIS POINT THE PATIENT WAS ON ASPIRIN AND PLAVIX. AT ONE MONTH POST-PROCEDURE, THE PATIENT STOPPED TAKING PLAVIX. THE PATIENT WAS SEEN BY HER PRIMARY CARDIOLOGIST ON (B)(6) 2020 AND A THROMBUS WAS NOTED ON THE RIGHT ATRIAL DISC. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON HEPARIN. THE THROMBUS BECAME SMALLER AND THE PATIENT WAS DISCHARGED ON ELIQUIS ON (B)(6) 2020. IT WAS FURTHER REPORTED THAT THE PATIENT TESTED POSITIVE FOR HETEROZYGOUS FACTOR V LEIDEN, WHICH MAY LEAD TO AN INCREASED RISK OF DEVELOPING BLOOD CLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166366 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES ASD37A 20836439 00733132636501

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention