BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 9152538 · Received October 3, 2019

    Report

    Report Number
    2017233-2019-00980
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 14, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    UDI-DI
    00733132636518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: CORRECTED FROM 3221 TO 213. A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET.

    Additional Manufacturer Narrative · 0

    ADDED H.6. DEVICE CODE 1: 3026.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050006. (B)(4). THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE NOTE THAT REMOVAL OF THE OCCLUDER SHOULD BE CONSIDERED IF THE SELECTED OCCLUDER ALLOWS EXCESSIVE SHUNTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44 MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 26 MM. THE EVENING OF THE PROCEDURE AN ECHOCARDIOGRAM SHOWED A RESIDUAL SHUNT THAT WAS NOT SEEN FOLLOWING DEVICE IMPLANT. THE PHYSICIAN REMOVED THE DEVICE IN A TRANSCATHETER PROCEDURE. THE DEFECT WAS NOT CLOSED AND THE PATIENT WILL LIKELY BE SENT TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948119 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES 18481001A 00733132636518

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O