BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 15042426 · Received July 18, 2022

    Report

    Report Number
    2017233-2022-03133
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    July 15, 2021
    Report Date
    July 18, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    UDI-DI
    00733132636518
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: HADI BEAINI AND JAMIL A. ABOULHOSN. (2022) PERCUTANEOUS MANAGEMENT OF LATE OCCLUDER DISLODGEMENT: A CASE REPORT. INTERNATIONAL JOURNAL OF CARDIOLOGY CONGENITAL HEART DISEASE 8 (2022) 100369. 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 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.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BY GORE: ¿PERCUTANEOUS MANAGEMENT OF LATE OCCLUDER DISLODGEMENT: A CASE REPORT¿. PUBLISHED ONLINE - INTERNATIONAL JOURNAL OF CARDIOLOGY CONGENITAL HEART DISEASE 8 (2022) 100369. THE ARTICLE PRESENTS THE CASE OF A 65 FEMALE WITH A 2.5 CM ASD, LEFT ATRIAL HYPERTENSION, DEFICIENT RETROAORTIC RIM, MOBILE SEPTUM PRIMUM AND HYPERTROPHIED SEPTUM SECUNDUM. SHE UNDERWENT UNCOMPLICATED CLOSURE WITH A 44-MM GORE® CARDIOFORM ASD OCCLUDER (GCA). HOWEVER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FIVE WEEKS POST PROCEDURE AND WAS FOUND TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AT A RATE OF 158 BPM. FURTHER WORKUP SHOWED A DISLODGED GCA DEVICE DESPITE APPROPRIATE DEVICE PLACEMENT AND SIZE SELECTION BASED ON THE PUBLISHED INSTRUCTIONS FOR USE. WE ELECTED TO NOT REMOVE THE 44-MM GCA GIVEN THAT IT HAD BECOME ADHERENT TO THE SEPTUM PRIMUM BUT INSTEAD USED THE STIFFER AMPLATZER SEPTAL OCCLUDER TO STABILIZE THE GCA AND OCCLUDE THE RESIDUAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2894466 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC. ASD44A 00733132636518

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other