BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 21909955 · Received April 25, 2025

    Report

    Report Number
    2017233-2025-06112
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    March 30, 2025
    Report Date
    April 25, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANT DATE AND PATIENT INFORMATION ARE UNKNOWN. ARTICLE CITATION: PARASCHIV C, SIMARD T, MEMIS H, PISLARU S, RIHAL CS. A CHALLENGING MITRAL VALVE REPAIR: DUAL MITRAL VALVE INTERVENTION COMPLICATED WITH OCCLUDER MALFUNCTION. J AM COLL CARDIOL. 2025;85(12):4166. DOI:10.1016/S0735-1097(25)04650-9. 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 REPORTED ON THE USE OF A 20MM GORE® CARDIOFORM SEPTAL OCCLUDER. TRANSCATHETER EDGE-TO-EDGE REPAIR [TEER] REVEALED THE LEFT ATRIAL APPENDAGE WAS OCCLUDED AND MODERATE RESIDUAL MR BETWEEN THE 2 CLIPS WHICH WORSENED TO SEVERE AT FOLLOW-UP. DUE TO PERSISTENT SYMPTOMATIC MR, 2 MONTHS LATER THE PATIENT UNDERWENT SUCCESSFUL CLOSURE OF INTER-CLIP REGURGITATION; AN AMPLATZER VASCULAR PLUG II WAS UNSTABLE SO A 20MM GORE CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED. MR WAS REDUCED TO MODERATE AND THE MEAN TRANSMITRAL GRADIENT WAS 3 MMHG. TEE SIX MONTHS LATER REVEALED AN OVAL SHAPED HYPERECHOGENICSTRUCTURE ON THE ATRIAL SIDE OF THE MITRAL VALVE SEEN IN SYSTOLE. IT WAS A PROLAPSE OF THE ATRIAL SIDE OF THE OCCLUDER INTO THE LEFT ATRIUM, WHICH SUSTAINED SYSTOLIC CONTACT WITH THE WATCHMAN DEVICE, BUT MR WAS STILL ONLY MODERATE. AFTER ONE MORE YEAR, THE ATRIAL SIDE OF THE OCCLUDER DEVICE WAS FOUND TO BE FRACTURED WITH MODERATE TO SEVERE MR. DUE TO HIGH SURGICAL RISK AND ADVANCED HEPATIC AND RENAL FAILURE, A CONSERVATIVE TREATMENT WAS DECIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289101 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Other