BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 21932113 · Received April 30, 2025

    Report

    Report Number
    2017233-2025-06120
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 30, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H6: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. H6: CODE D12: ACCORDING TO THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA, SUCH AS ATRIAL FIBRILLATION OR FLUTTER, REQUIRING TREATMENT. LITERATURE TITLE: HEMODYNAMIC CHANGES AFTER WIRE FRAME OCCLUDERS VS. METAL MESH DEVICES FOR ATRIAL SEPTAL DEFECT. SOURCE: CIRCULATION JOURNAL. IN PRESS. DOI: 10.1253/CIRCJ.CJ-24-0966. 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 PUBLISHMENT WAS REVIEWED BY GORE: TITLE: HEMODYNAMIC CHANGES AFTER WIRE FRAME OCCLUDERS VS. METAL MESH DEVICES FOR ATRIAL SEPTAL DEFECT. SOURCE: CIRCULATION JOURNAL. IN PRESS. DOI: 10.1253/CIRCJ.CJ-24-0966. BACKGROUND: TRANSCATHETER ATRIAL SEPTAL DEFECT (ASD) CLOSURE IS THE FIRST TREATMENT OPTION FOR SECUNDUM ASD, BUT PARAMETERS FOR OPTIMAL DEVICE SELECTION HAVE NOT BEEN ESTABLISHED. WE COMPARED OUTCOMES BETWEEN OCCLUDERS WITH A WIRE FRAME AND METAL MESH DEVICES. METHODS AND RESULTS: THIS STUDY INCLUDED SECUNDUM ASD PATIENTS IMPLANTED WITH A WIRE FRAME OCCLUDER (GORE® CARDIOFORM ASD OCCLUDER [GCA]) OR METAL MESH DEVICES (AMPLATZER SEPTAL OCCLUDER DEVICE [ABBOTT] AND OCCLUTECH FIGULLA FLEX II DEVICE [OCCLUTECH]). THE PRESENCE OF RESIDUAL SHUNT AND B-TYPE NATRIURETIC PEPTIDE (BNP) LEVELS AFTER IMPLANTATION WERE COMPARED. OF THE 970 PATIENTS WITH EITHER GCA (N=48) OR A METAL MESH DEVICE (N=922; CONTROL), 42 PATIENTS FROM EACH GROUP WERE ANALYZED AFTER PROPENSITY SCORE MATCHING. THE PREVALENCE OF RESIDUAL SHUNT WAS SIGNIFICANTLY LOWER IN THE GCA GROUP 1 DAY AND 1 MONTH AFTER IMPLANTATION (P<0.001 AND P=0.017, RESPECTIVELY), WHEREAS THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS 6 MONTHS LATER (P=0.088). BNP LEVELS AT 1 MONTH WERE SIGNIFICANTLY HIGHER IN THE GCA GROUP (RATIO OF CHANGE 1.36; 95% CONFIDENCE INTERVAL [CI] 1.01¿1.83), BUT DID NOT DIFFER SIGNIFICANTLY BETWEEN THE 2 GROUPS AT 6 MONTHS (RATIO OF CHANGE 1.04; 95% CI 0.65¿1.65). PROCEDURAL RESULTS AT 6 MONTHS WERE REPORTED AS BELOW: BLEEDING AT ANOTHER SITE FOR VASCULAR ACCESS 1 (2.4%), TRANSIENT FEVER 4 (9.5%), PAROXYSMAL/PERSISTENT ATRIAL FIBRILLATION 3 (7.1%), PALPITATIONS WITHOUT AN ELECTROCARDIOGRAM RECORD 6 (14.3%), ACUTE PULMONARY CONGESTION 1 (2.4%), PARALYTIC ILEUS AFTER GENERAL ANESTHESIA 1 (2.5%), WIRE FRAME FRACTURE AT 1 MONTH 4 (9.5%), WIRE FRAME FRACTURE AT 6 MONTHS 8 (19.0%). ALSO, RESIDUAL SHUNT AT 1 DAY 9 (21.4%), AT 1 MONTH 5 (11.9%), AT 6 MONTHS 1 (2.5%) WERE REPORTED. CONCLUSIONS: PATIENTS IMPLANTED WITH A WIRE FRAME OCCLUDER HAD A LOWER PREVALENCE OF RESIDUAL SHUNT AND A GREATER INCREASE IN BNP LEVELS IN THE EARLY PERIOD AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463553 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other