BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® CARDIOVASCULAR PATCH

    MDR report key: 21615867 · Received March 17, 2025

    Report

    Report Number
    3007284313-2025-03830
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    November 24, 2023
    Report Date
    June 27, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K811841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: VON STUMM, M. ET AL: "MID-TERM RESULTS FOLLOWING PULMONARY ARTERY PATCH AUGMENTATION IN CONGENITAL HEART DISEASE", TRANSL PEDIATR 2023;12(11):1992-2000 / HTTPS://DX.DOI.ORG/10.21037/TP-23-382. PUBLISHED ONLINE NOV 24, 2023. DOI: 10.21037/TP-23-382. EMDR SECTION H6: CODES HAVE BEEN ADDED/UPDATED TO REFLECT THE EXTENT OF THE INVESTIGATION PERFORMED. H6, COMPONENT CODE: ADDED CODE G07001. H6. TYPE OF INVESTIGATION: CODE B21 WAS WITHDRAWN. H6. INVESTIGATION FINDINGS: REPLACED CODE C21 WITH CODE C20. H6, INVESTIGATION CONCLUSIONS: ADDED CODES D15, D12. CODE C20: NO SERIAL NUMBERS FOR THE IMPLANTED DEVICES COULD BE OBTAINED. IT APPEARS THAT THE DEVICES REMAIN IMPLANTED AND NO DEVICE EVALUATIONS COULD BE PERFORMED. GORE CONTACTED THE CORRESPONDING AUTHOR MULTIPLE TIMES TO OBTAIN ADDITIONAL INFORMATION. AS NO RESPONSES WERE RECEIVED, THIS EVENT WAS PROCESSED WITH THE INFORMATION RETRIEVED FROM THE LITERATURE ARTICLE.

    Additional Manufacturer Narrative · 0

    A1, PATIENT IDENTIFIER (IN CONFIDENCE): NO SPECIFIC DETAILS FOR PATIENTS WITH AN IMPLANTED GORE DEVICE RELATED TO ADVERSE EVENTS REPORTED IN THE ARTICLE HAVE BEEN PROVIDED. THEREFORE, DATA PROVIDED REFLECT GORE'S INTERNAL NUMBER FOR THIS CASE. THE DEVICES REMAIN IMPLANTED. GORE INTENDS TO CONTACT THE CORRESPONDING AUTHOR FOR ADDITIONAL INFORMATION. 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

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: VON STUMM, M. ET AL: "MID-TERM RESULTS FOLLOWING PULMONARY ARTERY PATCH AUGMENTATION IN CONGENITAL HEART DISEASE", TRANSL PEDIATR 2023;12(11):1992-2000 / HTTPS://DX.DOI.ORG/10.21037/TP-23-382. PUBLISHED ONLINE NOV 24, 2023. DOI: 10.21037/TP-23-382. BETWEEN JANUARY 2012 AND DECEMBER 2018, THIS RETROSPECTIVE, SINGLE-CENTER COHORT STUDY INCLUDED 156 MAJORLY MALE PATIENTS (54%) WITH 135 INFANTS AGED BELOW ONE YEAR (82%) WHO UNDERWENT SURGICAL PATCH AUGMENTATION TO SURGICALLY TREAT TYPES OF PULMONARY ARTERY STENOSIS (PAS) IN BIVENTRICULAR CONGENITAL HEART DISEASE (UNDERLYING TETRALOGY OF FALLOT DISEASE) USING DIFFERENT PATCH MATERIALS. THE AIM OF THE STUDY WAS TO COMPARE THE OUTCOMES OF THE TREATMENT. THE FOUR PATCH MATERIALS USED WERE: GLUTARALDEHYDE FIXATED AUTOLOGOUS PERICARDIUM (AP), EPTFE) GORE-TEX® CARDIOVASCULAR PATCH, EQUINE PERICARDIUM (EP) (MATRIX PATCH¿, AND BOVINE PERICARDIUM (BP) (CARDIOCEL®). ARTERIOPLASTY OF PAS WAS PERFORMED WITH THE IMPLANTATION OF PATCH MATERIAL TO THE MAIN PULMONARY ARTERY (MPA), INCLUDING TRANSANNULAR PATCHES (TAPS), THE LEFT PULMONARY ARTERY (LPA) AND RIGHT PULMONARY ARTERY (RPA). THE PRIMARY STUDY ENDPOINT WAS THE COMPOSITE OF CATHETER-BASED RE-INTERVENTION OR RE-OPERATION TO RELIEVE RECURRENT STENOSIS AT THE SITE OF PRIOR IMPLANTED PATCH MATERIAL. THE STUDY FOUND THAT OVERALL, THERE WERE 11 EARLY AND 19 LATE RE-INTERVENTIONS WITH A MEDIAN TIME OF 3 MONTHS UNTIL THE RE-INTERVENTION WAS PERFORMED. THE ARTICLE STATES THAT SURGICAL ENLARGEMENT OF PULMONARY BRANCH ARTERIES AS WELL AS RELIEF OF RECURRENT OBSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT WERE NECESSARY RE-INTERVENTIONS IN 54% AND 46% OF PATIENTS, RESPECTIVELY. CATHETER-BASED REINTERVENTIONS AS STENT INSERTIONS (53%) AND BALLOON ANGIOPLASTIES (36%) FOR RECURRENT PAS WERE PERFORMED FOR 53% AND 36% OF PATIENTS, RESPECTIVELY, FOR RECURRENT PAS. FOR THE GORE-TEX¿ CARDIOVASCULAR PATCH, THE ARTICLE REPORTS 6 REINTERVENTIONS FOR THE TAP PLACEMENT, 3 INTERVENTIONS FOR THE MAP, 3 INTERVENTIONS FOR THE LPA AND 2 INTERVENTIONS FOR THE RPA IMPLANT SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15202 GORE-TEX® CARDIOVASCULAR PATCH PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Male Required Intervention