BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 22784825 · Received August 12, 2025

    Report

    Report Number
    2017233-2025-06500
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    September 24, 2024
    Report Date
    August 13, 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

    BIATRIAL THROMBI ON A GORE SEPTAL OCCLUDER DESPITE EARLY EPITHELIALIZATION, PEDIATRIC CARDIOLOGY (2024). HTTPS://DOI.ORG/10.1007/S00246-024-03656-W. 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.

    Additional Manufacturer Narrative · 0

    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 PUBLICATION WAS REVIEWED: BIATRIAL THROMBI ON A GORE SEPTAL OCCLUDER DESPITE EARLY EPITHELIALIZATION, PEDIATRIC CARDIOLOGY (2024). HTTPS://DOI.ORG/10.1007/S00246-024-03656-W. (B)(6). THE ARTICLE WAS PUBLISHED 09/24/2024. SUMMARY: A 15-YEAR-OLD PREVIOUSLY HEALTHY FEMALE PRESENTED WITH RIGHT FLANK PAIN AND WAS DIAGNOSED WITH A RIGHT RENAL INFARCTION. INITIAL ANTICOAGULATION WITH HEPARIN WAS TRANSITIONED TO ENOXAPARIN AND SUBSEQUENTLY TO RIVAROXABAN. HER ONLY IDENTIFIABLE THROMBOTIC RISK FACTOR WAS THE USE OF ORAL CONTRACEPTIVE PILLS (OCPS). A FULL COAGULOPATHY WORKUP WAS UNREMARKABLE. EVALUATION REVEALED A PATENT FORAMEN OVALE (PFO), WHICH WAS CLOSED PERCUTANEOUSLY USING A 25-MM GORE SEPTAL OCCLUDER. SHE WAS DISCHARGED ON 325 MG ASPIRIN, AND RIVAROXABAN WAS DISCONTINUED. THE PATIENT MISSED HER CARDIOLOGY FOLLOW-UP, RESUMED OCPS, AND DISCONTINUED ASPIRIN TWO MONTHS POST-PROCEDURE. THREE MONTHS AFTER DEVICE PLACEMENT, SHE PRESENTED WITH RIGHT LOWER EXTREMITY PAIN, BUT DVT WAS RULED OUT. TWO WEEKS LATER, SHE RETURNED WITH LEFT FLANK PAIN AND VOMITING. IMAGING REVEALED A LEFT RENAL INFARCTION, PARTIAL THROMBOSIS OF THE LEFT RENAL ARTERY, AND A SMALL PULMONARY EMBOLISM. LABORATORY FINDINGS INCLUDED THROMBOCYTOPENIA AND ACUTE KIDNEY INJURY. ECHOCARDIOGRAPHY SHOWED THE DEVICE IN PLACE WITH NO RESIDUAL SHUNT BUT REVEALED THROMBI ON BOTH ATRIAL DISKS (12×15 MM ON THE RIGHT, 7 MM ON THE LEFT). SHE WAS TREATED WITH TWO ROUNDS OF SYSTEMIC TPA, RESULTING IN IMPROVED RENAL PERFUSION AND REDUCTION IN THROMBUS SIZE. ANTICOAGULATION WITH HEPARIN WAS RESUMED AND TRANSITIONED TO ENOXAPARIN WITH ASPIRIN. ALTHOUGH INITIAL FOLLOW-UP SHOWED RESOLUTION OF THROMBI, A SUBSEQUENT ECHOCARDIOGRAM REVEALED A NEW THROMBUS ON THE LEFT ATRIAL DISK. SHE UNDERWENT SURGICAL REMOVAL OF THE DEVICE AND ATRIAL SEPTAL DEFECT (ASD) CLOSURE WITH A BOVINE PERICARDIAL PATCH. THE DEVICE WAS FULLY ENDOTHELIALIZED WITH NO VISIBLE THROMBUS AT THE TIME OF REMOVAL. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON THERAPEUTIC ENOXAPARIN AND ASPIRIN FOR SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419828 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown