BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 11824134 · Received May 14, 2021

    Report

    Report Number
    2017233-2021-02004
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 14, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRERELEASE SPECIFICATIONS. ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: THROMBOSIS OR THROMBOEMBOLIC EVENT RESULTING IN CLINICAL SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE A 25MM GORE¿ CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATIENT WITH PATENT FORAMEN OVALE (PFO). THE PFO CLOSURE PROCEDURE ON THE (B)(6) 2021 WENT ON WITHOUT COMPLICATIONS, THE PATIENT RECEIVED NON-FRACTIONATED HEPARIN (HNF) AND THEN DUOPLAVIN WITHOUT INTERRUPTION. IN THE FOLLOWING DAYS, THE PATIENT COMPLAINED OF PAROXYSMAL HEADACHES. DAY 14 AFTER IMPLANTATION, (B)(6), THE DEVICE WAS REPORTED TO BE IN GOOD POSITION. THE PATIENT DESCRIBED A LIMP ON EXERTION OF HIS RIGHT LEG. ON (B)(6), IT WAS REPORTED THAT THE PATIENT SUFFERED ISCHEMIA OF THE RIGHT LOWER LIMB, POPLITEAL EMBOLISM, AND BILATERAL PULMONARY EMBOLISM. THE PLATELET COUNT WAS 36G/L. THE PATIENT WAS HOSPITALIZED FOR VASCULAR SURGERY. THE DOPPLER SHOWED A COMPLETE THROMBOSIS OF THE POPLITEAL ARTERY. AND DUE TO THE THROMBOCYTOPENIA, THE SURGERY WASNT REALIZED. A 28MM THROMBUS WAS DISCOVERED IN THE LEFT ATRIUM AGAINST THE LEFT DISC OF THE GORE¿ CARDIOFORM SEPTAL OCCLUDER DEVICE. ON (B)(6), IT WAS REPORTED THAT THE PATIENT SUFFERED FROM FLOATING THROMBOSIS AT THE ORIGIN OF THE RIGHT INTERNAL CAROTID ARTERY WITH OCCLUSION TO THE T CAROTID. NO STROKE WAS REPORTED. ON (B)(6), TRANS OESOPHAGEAL ECHOCARDIOGRAM SHOWED THROMBUS PROGRESSED ON THE LEFT AND THE RIGHT DISC OF THE GORE¿ CARDIOFORM SEPTAL OCCLUDER DEVICE (29X13MM ON THE LEFT, 14X10MM ON THE RIGHT). THE PATIENT UNDERWENT INTRACARDIAC THROMBECTOMY AND GORE¿ CARDIOFORM SEPTAL OCCLUDER DEVICE WAS EXPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD HEPARIN-INDUCED THROMBOCYTOPENIA WITH PRESENCE OF ANTI-PF4 ANTIBODIES. THE PATIENT WAS TREATED WITH ARGATROBAN AND IMMUNOGLOBULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721141 GORE CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R