BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9010772 · Received September 12, 2019

    Report

    Report Number
    2017233-2019-00853
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    July 10, 2018
    Report Date
    December 16, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: G5. COMBINATION PRODUCT. G5. PRE-1938. G5. OTC PRODUCT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. NOTE: THE ARTICLE PUBLISH DATE IS 10 JULY 2018. (B)(6) 2018 WILL BE REFERENCED AS THE DATE OF EVENT.

    Description of Event or Problem · 1

    LITERATURE ARTICLE "PERCUTANEOUS RETRIEVAL OF MIGRATED VIABAHN STENT FROM A SEGMENTAL PULMONARY ARTERY"; R. C. ZVAVANJANJA, M.D.; CVIR ENDOVASCULAR (2018) 1:1 HTTPS://DOI.ORG/10.1186/S42155-018-0007-3; WAS REVIEWED. THE PURPOSE OF THE ARTICLE IS THE DOCUMENT A SINGLE CASE REPORT DESCRIBING A GORE® VIABAHN® ENDOPROSTHESIS RETRIEVAL FROM THE SEGMENTED PULMONARY ARTERY USING ENDOVASCULAR TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810947 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention