BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE® PERICARDIAL MEMBRANE

    MDR report key: 6039076 · Received October 19, 2016

    Report

    Report Number
    2017233-2016-00805
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    December 1, 2010
    Report Date
    October 19, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DXZ
    PMA / PMN Number
    K012098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE WAS NOT RETURNED, THEREFORE, NO FURTHER EVALUATION COULD BE CONDUCTED.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THE FOLLOWING WAS REPORTED BY THE AUTHORS: (B)(4). THE ARTICLE STATES THAT ON AN UNKNOWN DATE, THE PATIENT WAS GIVEN BIRTH WITH THORACO-ABDOMINAL ECTOPIA CORDIS, THEREFORE IMMEDIATELY AFTER THE BIRTH, UNDERWENT SURGICAL REPAIR OF THE ECTOPIA CORDIS AND THORACO-ABDOMINAL WALL RECONSTRUCTION. DURING THE SURGERY, A GORE-TEX® SHEET (PRODUCT NAME NOT SPECIFIED) WAS USED TO THE DEFECTED EPICARDIUM AND LOWER PART OF THE STERNUM IN ORDER TO FIX THE POSITION OF THE PROTRUDED HEART WITHIN THE THORAX. THE PATIENT TOLERATED THE SURGERY. AFTER THE SURGERY ON THE SAME DAY, ECHOCARDIOGRAM AND CT IMAGING WERE PERFORMED AND CONFIRMED DOUBLE OUTLET RIGHT VENTRICLE, STENOSIS OF THE PULMONARY ARTERY, AND ARTERIAL SEPTAL DEFECT. AT THE AGE OF TWO MONTHS AND NINE MONTHS RESPECTIVELY, THE PATIENT UNDERWENT RIGHT AND LEFT BLALOCK-TAUSSIG SHUNTS FOR THE PALLIATIVE TREATMENT OF THE CONGENITAL HEART DEFECTS. THE ARTICLE FURTHER STATES THAT AT THE AGE OF TEN MONTHS, THE DEHISCENCE OF THE THORACIC INCISION WAS IDENTIFIED. THE GORE-TEX® SHEET WAS EXPOSED FROM THE INCISION, WHICH CAUSED TO DEVELOP INTRACTABLE ULCER, AND THE PATIENT WAS HOSPITALIZED. THE BACTERIAL CULTURE UPON THE HOSPITALIZATION WAS NEGATIVE. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGICAL REPAIR OF THE INTRACTABLE ULCER. THE GORE-TEX® SHEET WAS NOT REMOVED CONSIDERING RISK OF BLEEDING DURING ITS REMOVAL. THE PATIENT TOLERATED THE SURGERY; HOWEVER DURING THE FOLLOW-UP, THE BACTERIAL CULTURE OF THE INCISION DETECTED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA), AND AT FIFTY-SIXTH DAY AFTER THE INITIAL SURGICAL REPAIR OF THE ULCER THE PATIENT WAS RE-HOSPITALIZED DUE TO RECURRENCE OF THE ULCER. THE ULCER ENLARGED, AND THE GORE-TEX® SHEET WAS AGAIN EXPOSED FROM THE BOTTOM OF THE ULCER. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ANOTHER SURGICAL REPAIR, AND THE GORE-TEX® SHEET WAS REMOVED FROM THE PATIENT. FIBROUS MEMBRANE DEVELOPED AROUND THE HEART AS ALTERNATIVE OF THE EPICARDIUM, THEREFORE NO FURTHER GORE-TEX® SHEET WAS IMPLANTED. THERE WAS NO SIGN OF INFECTION AT THE MEDIASTINUM. RECTUS ABDOMINIS MUSCULOCUTANEOUS FLAP WAS THEN PLACED AND COVERED THE ULCER. AFTER THE SECOND SURGICAL REPAIR, THE PATIENT WAS DOING WELL, AND DISCHARGED TEN DAYS AFTER THE SURGERY. IT WAS STATED IN THE ARTICLE THAT AT REPAIR OF THORACO-ABDOMINAL ECTOPIA CORDIS GORE-TEX® SHEET IS OFTEN USED AS COVERAGE OF DEFECT EPICARDIUM. WHEN SKIN OF THORACIC WALL COVERING GORE-TEX® SHEET IS THIN, AND GORE-TEX® SHEET CONTINUES TO BE UNDER PRESSURE AND TENSION FROM HEARTBEAT, THERE IS A POSSIBILITY THAT THE SHEET IS EXPOSED AND THEN INFECTED, LIKE THE CASE REPORTED IN THE ARTICLE. IT WAS ALSO STATED IN THE ARTICLE THAT THE CAUSE OF THE INFECTION IN THE CASE MIGHT BE DUE TO THE UNREMOVED GORE-TEX® SHEET, AND INSUFFICIENT DEBRIDEMENT DURING THE FIRST REPAIR OF THE ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691009 GORE PRECLUDE® PERICARDIAL MEMBRANE PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization| R