BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 9457747 · Received December 12, 2019

    Report

    Report Number
    2017233-2019-01236
    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

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE A 30MM 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. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255680 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 20867220

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R