BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 21953776 · Received May 2, 2025

    Report

    Report Number
    2017233-2025-06138
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    March 30, 2025
    Report Date
    May 2, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GORE® CARDIOFORM SEPTAL OCCLUDER INSTRUCTIONS FOR USE STATES: POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO:DEVICE FAILURE OR INEFFECTIVENESS REQUIRING REPEAT ATRIAL SEPTAL DEFECT INTERVENTIONS OR PROCEDURES ENDOCARDITIS.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 HAVE NOT 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 PUBLICATION WAS REVIEWED: PATENT FORAMEN OVALE CLOSURE DEVICE ENDOCARDITIS, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOLUME 85, ISSUE 12, SUPPLEMENT, 2025, PAGE 3123, ISSN 0735-1097. BERNIECE JOHNSON, STEFAN MILUTINOVIC, JUAN C. PEREZ, CONNOR MCCASKEY, RICARDO ORLANDO ESCARCEGA ALARCON, DAVID CERVANTES, KAMALDEEP SINGH. THE ARTICLE WAS PUBLISHED 03/30/2025. SUMMARY: THIS WAS A CASE OF A 58-YEAR-OLD MALE WITH PRIOR CRYPTOGENIC STROKE WHO PRESENTED WITH FEVER AND LEFT HIP PAIN. HE HAD UNDERGONE TRANSCATHETER PATENT FORAMEN OVALE CLOSURE (PFO) WITH A GORE® CARDIOFORM SEPTAL OCCLUDER (W.L. GORE & ASSOCIATES) SIX WEEKS PRIOR IN AN OUTSIDE INSTITUTION. MRI OF THE HIP SHOWED MODERATE JOINT EFFUSION AND ULTRASOUND-GUIDED ASPIRATION SHOWED SEPTIC ARTHRITIS. BLOOD AND ASPIRATION CULTURES WERE POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) AFTER WHICH HE UNDERWENT HIP IRRIGATION DEBRIDEMENT. ADDITIONALLY, HE UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WHICH SHOWED DEVICE IN THE MID INTRA-ATRIAL SEPTUM WITH LEFT ATRIAL SIDE VEGETATION AND RIGHT ATRIAL SIDE VEGETATION, BUT NO VALVE ENDOCARDITIS. HE UNDERWENT DEVICE REMOVAL WITH AUTOLOGOUS PERICARDIAL PATCH CLOSURE OF RESULTANT PFO. HE WAS DISCHARGED ON VANCOMYCIN AND CEFTAROLINE FOR TOTAL OF 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191807 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other