BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 20975820 · Received December 19, 2024

    Report

    Report Number
    2017233-2024-05635
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    October 23, 2024
    Report Date
    March 18, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EMDR SECTION H6: CODES HAVE BEEN ADDED/UPDATED TO REFLECT THE EXTENT OF THE INVESTIGATION PERFORMED. H6, HEALTH EFFECT - CLINICAL CODE: REPLACED CODE E2401 WITH E060103. H6, HEALTH EFFECT - IMPACT CODE: REPLACED CODE F24 WITH F2303 H6, INVESTIGATION FINDINGS, CODE C20: THE SERIAL NUMBERS FOR THE DEVICES USED IN THE STUDY PATIENTS COULD NOT BE OBTAINED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS WAS NOT PERFORMED. H6, INVESTIGATION FINDINGS, CODE C0106: REFERS TO SUSPECTED THROMBUS ACTIVATION OF THE IMPLANTED DEVICE. ACCORDING TO THE GORE® CARDIOFORM SEPTAL OCCLUDER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA REQUIRING TREATMENT. AND THROMBOSIS OR THROMBOEMBOLIC EVENT RESULTING IN CLINICAL SEQUELAE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: KAYVANPOUR, E. ET AL. "COMPARATIVE EFFECTIVENESS OF DEVICES FOR INTERVENTIONAL PATENT FORAMEN OVALE CLOSURE: INSIGHTS FROM A 23-YEAR MONOCENTRIC ANALYSIS", J. CLIN. MED. 2024, 13(21), 6354; HTTPS://DOI.ORG/10.3390/JCM13216354. PUBLISHED: 23 OCTOBER 2024. A1: PATIENT IDENTIFIER: 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. D6A, IMPLANT DATE: THE STUDY RANGE PROVIDED IN THE ARTICLE IS JANUARY 2000 TO FEBRUARY 2023. GORE HAS THEREFORE DETERMINED JANUARY 1, 2000 AS A BEST ESTIMATE DATE OF IMPLANT. E1, INITIAL REPORTER NAME AND ADDRESS: CORRESPONDING AUTHOR EMAIL IS: [email protected] GORE INTENDS TO CONTACT THE CORRESPONDING AUTHOR OF THE ARTICLE FOR ADDITIONAL INFORMATION. FURTHER INVESTIGATION IS BEING CONDUCTED AND WILL BE INCLUDED IN THE FINAL REPORT. 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

    THIS RETROSPECTIVE, OBSERVATIONAL STUDY AT A MONOCENTRIC SITE INCLUDED 716 PATIENTS TO TREAT THE CONDITION OF A PATENT FORAMEN OVALE (PFO) BETWEEN JANUARY 2000 AND FEBRUARY 2023. THE FOUR PFO CLOSURE DEVICES USED WERE AMPLATZER PFO OCCLUDER (N = 227), OCCLUTECH PFO OCCLUDER (N = 106), CARDIA PFO-STAR (N = 87) AND GORE® CARDIOFORM SEPTAL OCCLUDER (N = 296) . THE COHORT¿S MEAN AGE WAS 50.6 ± 12.6 YEARS, WITH 60.8% FEMALE. KEY ENDPOINTS WERE PUNCTURE SITE COMPLICATIONS, PERICARDIAL EFFUSION, RECURRENT STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA), DEVICE THROMBUS, NEW-ONSET ATRIAL FIBRILLATION, AND DEATH. MOST COMMON INDICATIONS FOR PFO CLOSURE WERE CRYPTOGENIC STROKE (66,8%) TRANSITORY ISCHEMIC ATTACK (TIA, 18%), PERIPHERAL EMBOLISM (6%) AND OTHERS. IMPLANT PROCEDURES WERE PERFORMED UNDER CONSCIOUS SEDATION BY EXPERIENCED CARDIOLOGISTS AND UNDER FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING FOR THE PURPOSE OF ACCURATE DEVICE POSITIONING AND MONITORING FOR POTENTIAL PROCEDURAL COMPLICATIONS. POST PFO CLOSURE, PATIENTS WERE TREATED WITH DUAL ANTIPLATELET THERAPY FOR A ONE MONTH PERIOD. ADDITIONALLY, ASPIRIN THERAPY WAS PRESCRIBED IF PATIENTS HAD ADDITIONAL RISK FACTORS OR IN CASES OF A RESIDUAL SHUNT. FOR THE GORE® CARDIOFORM SEPTAL OCCLUDER, THE ARTICLE REPORTS THAT 296 PATIENTS WITH A MEAN AGE OF 50.3 ± 12.4 YEARS (PREDOMINATELY MALE) RECEIVED THIS DEVICE AND AN INITIAL PROCEDURAL SUCCESS RATE OF 99.3% WAS ACHIEVED. DURING THE FIRST 12 MONTHS FOLLOW-UP PERIOD, THE FOLLOWING POSTPROCEDURAL ADVERSE EVENTS WERE REPORTED: 26 PATIENTS EXPERIENCED NEW ONSET ARRHYTHMIA (ATRIAL FIBRILLATION, ATRIAL FLUTTER), AND A DEVICE THROMBUS WAS PRESENT IN 16 PATIENTS. FOR ALL DEVICES AND OVER 12 MONTHS, THE STUDY CONCLUDES THAT PFO CLOSURE IS A SAFE AND EFFICIENT WAY TO PREVENT RECURRENT STROKES WITH HIGH SUCCESS RATE AND VARYING, DEVICE DEPENDENT SPECIFIC COMPLICATION PROFILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023269 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention