BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9654405 · Received January 31, 2020

    Report

    Report Number
    2017233-2020-00062
    Event Type
    Injury
    Date Received
    January 31, 2020
    Date of Event
    August 7, 2019
    Report Date
    February 17, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CORRECTED CONCLUSION CODE. THE GORE® CARDIOFORM SEPTAL OCCLUDER INSTRUCTIONS FOR USE STATES: ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ARRHYTHMIA 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 AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". 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 · 1

    PMA/510K #P050006.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED THROUGH THE CLINICAL STUDY (B)(6): IT WAS REPORTED THE PHYSICIAN IMPLANTED A 37MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT PRESENTED WITH ATRIAL FLUTTER AND WAS TREATED ON (B)(6) 2019 WITH RHYTHM CONTROL MEDICATION AND CARDIOVERSION. ON (B)(6) 2020 THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION AND ON (B)(6) 2020 WAS TREATED WITH CONTINUATION OF ARRHYTHMIA MEDICATION AND CARDIOVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114700 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 17588556

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention