BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PROPATEN® VASCULAR GRAFT

    MDR report key: 11496114 · Received March 16, 2021

    Report

    Report Number
    2017233-2021-01768
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 22, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    UDI-DI
    00733132606412
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2- PRODUCT CODE, DSY PROSTHESIS, VASCULAR GRAFT UPDATED. G4- PMA/510(K)NUMBER, CORRECT TO K062161. H6 - INVESTIGATION FINDINGS, CORRECTED TO 213 (NO DEVICE PROBLEMS FOUND).

    Additional Manufacturer Narrative · 0

    H6 - INVESTIGATION FINDINGS, CODE UPDATED TO 3221 (NO FINDINGS AVAILABLE). H6 - INVESTIGATION CONCLUSIONS, CODE UPDATED TO 4315 (CAUSE NOT ESTABLISHED).

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM APL, WHICH IN COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY/NON-ELUTING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT WAS PLACED FOR TREATMENT OF SEVERE PULMONARY STENOSIS IN A PATIENT WITH TETRALOGY OF FALLOT (TOF). AT 1651 ON (B)(6) 2021, THE PATIENT CAME OUT OF THE OPERATING ROOM TO THE INTENSIVE CARE UNIT UNEVENTFULLY, AT 1830 AN EMERGENCY REDO STERNOTOMY EMERGENCY CARDIAC RESUSCITATION ON CARDIOPULMONARY BYPASS IN THE UNIT WAS PERFORMED, USING A 3FR FOGARTY ARTERIAL EMBOLECTOMY CATHETER TO DECLOT GRAFT AND FLUSHED WITH A HEPARINIZED SOLUTION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE PHYSICIAN STATED: THE THROMBOSIS POSSIBILITY FORMED DUE TO THE HYPERCOAGULABLE STATE OF THE BABY AND SMALL SIZE OF THE BRANCH PULMONARY ARTERY STENOSIS. ON (B)(6) 2021 PATIENT EXTUBATED AND PLACED ON CONTINUOUS POSITIVE AIRWAY PRESSURE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392079 GORE® PROPATEN® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W. L. GORE & ASSOCIATES, INC. HPT350010A 00733132606412

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Unknown Hospitalization| O