BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PRECLUDE® PERICARDIAL MEMBRANE

    MDR report key: 17266320 · Received July 6, 2023

    Report

    Report Number
    3007284313-2023-02600
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    May 8, 2022
    Report Date
    July 6, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K012098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KOBAYASHI ET AL (2022) ¿CONSTRICTIVE PERICARDITIS CAUSED BY PERICARDIAL SUBSTITUTION USING EXPANDED POLYTETRAFLUOROETHYLENE.¿ JOURNAL OF CARDIAC SURGERY. 2022 AUG; 37(8):2429-2431. EPUB 2022 MAY 8. PMID: 35526126. DOI: 10.1111/JOCS.16585. THE SECOND GORE® PRECLUDE® PERICARDIAL MEMBRANE DEVICE (PRODUCT NUMBER 20059714) FROM CASE (B)(6) IS INCLUDED IN THIS REPORT. THE GORE® PRECLUDE® PERICARDIAL MEMBRANE INSTRUCTIONS FOR USE STATES: ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE MAY INCLUDE BUT ARE NOT LIMITED TO: INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    KOBAYASHI ET AL (2022) ¿CONSTRICTIVE PERICARDITIS CAUSED BY PERICARDIAL SUBSTITUTION USING EXPANDED POLYTETRAFLUOROETHYLENE.¿ JOURNAL OF CARDIAC SURGERY. 2022 AUG; 37(8):2429-2431. EPUB 2022 MAY 8. PMID: 35526126. DOI: 10.1111/JOCS.16585. EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) IS COMMONLY USED AS A PERICARDIAL SUBSTITUTE DURING CARDIAC SURGERY TO PREVENT CARDIAC INJURY DURING RESTERNOTOMY. HOWEVER, ALTHOUGH RARE, CONSTRICTIVE PERICARDITIS ASSOCIATED WITH EPTFE HAS BEEN REPORTED. A RARE CASE OF CONSTRICTIVE PERICARDITIS DEVELOPED DUE TO SEVERE RESTRICTION OF CARDIAC MOTION ASSOCIATED WITH THE EPTFE MEMBRANE USED AS A PERICARDIAL SUBSTITUTE. HEMODYNAMIC IMPROVEMENT HAS BEEN ACHIEVED BY SURGICAL REMOVAL OF THE EPTFE MEMBRANE AND EXUDATES WITHIN THE OVERLAPPED PORTION OF THE EPTFE MEMBRANES, AND DISSECTION OF THE EPICARDIAL FIBROUS THICKENING. A 70-YEAR-OLD MAN UNDERWENT MITRAL VALVE PLASTY FOR MITRAL REGURGITATION THROUGH MEDIAN STERNOTOMY. TWO MONTHS LATER, HE REQUIRED PERICARDIECTOMY FOR CONSTRICTIVE PERICARDITIS VIA A RESTERNOTOMY APPROACH. TWO 0.1MM THICK EPTFE SHEETS (GORETEX ® EPTFE PATCH II/PERICARDIAL SHEET; W.L. GORE AND ASSOCIATES INC.) WERE UTILIZED AS A PERICARDIAL SUBSTITUTE FROM THE RIGHT PHRENIC NERVE TO THE LEFT ONE. EIGHT YEARS POSTOPERATIVELY, THE PATIENT COMPLAINED OF GRADUAL WORSENING OF EXERTIONAL FATIGUE AND SYSTEMIC EDEMA. COMPUTED TOMOGRAPHY (CT) REVEALED A RETROSTERNAL SOLID CYSTIC STRUCTURE COMPRESSING THE RIGHT HEART POSTERIORLY. TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED SEVERE DIASTOLIC DYSFUNCTION (WITH SEPTAL BOUNCE), A MARKEDLY DILATED INFERIOR VENA CAVA (38 MM), AND SIGNIFICANT RESPIRATORY VARIATION IN THE TRICUSPID PEAK E-WAVE (>40%). SEVERE TRICUSPID REGURGITATION WITH ANNULAR DILATATION WAS ALSO OBSERVED. CARDIAC CATHETERIZATION REVEALED THE CLASSICAL SQUARE ROOT SIGN IN BOTH VENTRICLES. CONSIDERING THESE FINDINGS, HE WAS DIAGNOSED WITH RECURRENT CONSTRICTIVE PERICARDITIS ASSOCIATED WITH THE EPTFE MEMBRANES. SURGICAL TREATMENT COMPRISING REMOVAL OF THE EPTFE MEMBRANE AND ADJUNCTIVE TRICUSPID VALVE PROCEDURE WAS PLANNED. EXTENSIVE HEART COVERAGE BY THE EPTFE MEMBRANE WAS OBSERVED FROM THE RIGHT ATRIUM TO THE VENTRICULAR APEX. BOTH EDGES OF THE EPTFE MEMBRANE WERE TIGHTLY ADHERENT TO THE CHEST WALL ON EACH SIDE, CAUSING STRONG TENSION IN THE MEMBRANE, WHICH POSTERIORLY COMPRESSED THE RIGHT HEART, LIKE A HARD SHELL, RESULTING IN SEVERE RESTRICTION OF CARDIAC MOTION. IN ADDITION, THE EPTFE MEMBRANES ARE PARTIALLY OVERLAPPED ONLY IN THE POSITION FROM THE ANTERIOR AND INFERIOR ASPECTS OF THE RIGHT HEART. THE POINT AT WHICH THE TWO MEMBRANES OVERLAPPED FORMED A PANCAKE-LIKE SPACE FILLED WITH INHOMOGENEOUS AND RELATIVELY FIRM INFLAMMATORY EXUDATES. COVERING THE HEART WITH AN EPTFE MEMBRANE IS EFFECTIVE IN PATIENTS WHO MIGHT UNDERGO REDO-STERNOTOMY IN THE FUTURE. HOWEVER, SURGEONS SHOULD KEEP IN MIND THE POSSIBILITY OF EPTFE RELATED EPICARDIAL INFLAMMATION AND EXUDATES RETENTION IN THE OVERLAPPED PORTION OF THE EPTFE SHEETS, WHICH MAY RESULT IN CONSTRICTIVE PERICARDITIS AND EPICARDITIS. WE BELIEVE THAT PERICARDIAL SUBSTITUTION WITH EPTFE MEMBRANES SHOULD BE APPLIED CAUTIOUSLY AND ONLY IN SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884652 GORE® PRECLUDE® PERICARDIAL MEMBRANE PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| H