BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 16156974 · Received January 13, 2023

    Report

    Report Number
    2017233-2023-03643
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 19, 2022
    Report Date
    February 3, 2023
    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

    THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE STATES: ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA, SUCH AS ATRIAL FIBRILLATION OR FLUTTER, REQUIRING TREATMENT. 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

    D4 AND H4: ADDED DEVICE INFORMATION. ADDED H6: CONCLUSION CODE H6: UPDATED B22 TO B14. UPDATED C20 TO C19.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT UNDERWENT TREATMENT TO CLOSE AN ATRIAL SEPTAL DEFECT USING A 48 MM GORE® CARDIOFORM ASD OCCLUDER. DURING LOCKING, A DELAYED LOCK RELEASED WAS NOTED. THIS WAS RESOLVED BY SHAKING OF THE HANDLE. THE RETRIEVAL CORD WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE ENDED. ON (B)(6) 2022, 48 HOURS LATER FROM THE INITIAL PROCEDURE, AN ATRIOVENTRICULAR BLOCK (MOBITZ) WAS OBSERVED FREQUENTLY. THE STEROID ADMINISTRATION WAS STARTED. ON (B)(6) 2022, THE PATIENT CONDITION WAS NOT IMPROVED YET SO THE STEROID ADMINISTRATION WAS CONTINUED. SINCE THE AFTERNOON OF (B)(6), MOBITZ WAS OBSERVED VERY FEW AND WENCKEBACH WAS OBSERVED. ON DECEMBER 21, 2022, IN THE MORNING, THE PATIENT CONDITION WAS RECOVERED TO ALMOST NORMAL AND WENCKEBACH WAS OBSERVED. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT WITH THE STEROID ADMINISTRATION BECAUSE THE PATIENT CONDITION WAS TENDED TO IMPROVE. THE PHYSICIAN STATED THAT THE DEVICE SIZE SELECTION HAD BEEN APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132324 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention| H