BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 9457658 · Received December 12, 2019

    Report

    Report Number
    2017233-2019-01235
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 22, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE A 30 MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6) 2019 TO CLOSE A PATENT FORAMEN OVALE IN A PATIENT WITH AN INDICATION OF STROKE. TWO DAYS AFTER IMPLANT THE PATIENT SUFFERED FROM FEVER AND ELEVATED INFECTION PARAMETERS (C-REACTIVE PROTEIN AND WHITE BLOOD CELLS). IT WAS REPORTED THE PATIENT RECEIVED HEPARIN PERIOPERATIVELY AND THAT THE ACCESS SITE CLOSURE WAS CARRIED OUT BY Z-SUTURE. IT WAS ALSO REPORTED THAT DUE TO THE LACK OF INCREASED COMORBIDITIES NO ANTIBIOTICS WERE GIVEN THROUGH THE INDEX PROCEDURE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS SUSPICIOUS FOR A LARGE ENDOCARDITIS/ THROMBUS ON THE RIGHT DISC. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251986 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 20700675

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R