BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE CARDIOFORM ASD OCCLUDER

    MDR report key: 10338270 · Received July 29, 2020

    Report

    Report Number
    2017233-2020-01062
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 13, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    UDI-DI
    00733132636501
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B3: CORRECTED DATE OF EVENT. D6: CORRECTED DATE OF IMPLANT. D7: CORRECTED DATE OF EXPLANT. 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 · 0

    H6: UPDATED CONCLUSION CODE IMAGING EVALUATION STATES: IMAGING FROM PERI-PROCEDURE WAS PROVIDED FOR REVIEW. TEE AND TTE FROM TWO DAYS POST IMPLANT WERE PROVIDED. THE DEVICE APPEARS TO BE IN A STABLE POSITION. IT APPEARS FROM THE IMAGING THAT A PORTION OF THE LEFT DISC MAY HAVE PROLAPSED INTO THE RIGHT ATRIUM AND WHAT APPEARS TO BE A SHUNT, ON TTE, IS PRESENT. HOWEVER, FROM THE IMAGING PROVIDED AN ADDITIONAL DEFECT CANNOT BE RULED OUT. ON TEE A PORTION OF THE RIGHT ATRIAL DISC IS NOT FULLY APPOSED TO SEPTUM AND APPEARS TO BE PROTRUDING INTO THE SVC. THE PATIENT WAS REFERRED FOR SURGERY TO HAVE THE DEVICE REMOVED AND SEPTUM REPAIRED. 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

    (B)(4). THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE STATES: POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: REPEAT PROCEDURE TO THE SEPTAL DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2020 TO TREAT AN ATRIAL SEPTAL DEFECT. THE FOLLOWING DAY A RESIDUAL SHUNT WAS NOTED. ON (B)(6) 2020, TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED THE RESIDUAL SHUNT HAD INCREASED AND THE PATIENT WAS TAKEN TO SURGERY WHERE THE DEVICE WAS REMOVED AND THE DEFECT SURGICALLY CLOSED. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804170 GORE CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC. ASD37A 00733132636501

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R