BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 10176855 · Received June 19, 2020

    Report

    Report Number
    2017233-2020-00446
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    May 22, 2020
    Report Date
    February 12, 2021
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    UDI-DI
    00733132605811
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: C1. NAME (#1) (B)(6); MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #6252642PP006. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 0

    H6. METHOD CODE 2 H6. RESULTS CODE 2. DEVICE FRAGMENTS OF A GORE® PROPATEN® VASCULAR GRAFT WERE RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED UNFIXED WERE FIVE GORE® PROPATEN® VASCULAR GRAFT FRAGMENTS. THE DEVICE FRAGMENTS HAD BEEN TRANSECTED PRIOR TO ARRIVAL AT W. L. GORE & ASSOCIATES. HISTOPATHOLOGIC ANALYSIS WAS NOT PERFORMED, DUE TO THE LACK OF FIXATION PRIOR TO ARRIVAL. THE DEVICE FRAGMENTS WERE SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. NO MATERIAL INTEGRITY CONCERNS WERE IDENTIFIED. THE MATERIAL DISRUPTIONS IDENTIFIED (TRANSECTIONS, RADIAL DISRUPTION, EVENLY SPACED SERRATION MARKS, FLATTENED/TORN MATERIAL, RADIAL FILM DISRUPTIONS, CANNULATION MARKS, ELECTROCAUTERY BURNS, TRANSMURAL PUNCTURES) ARE CONSISTENT WITH SURGICAL INSTRUMENTATION MANIPULATION (E.G., SCALPEL/SCISSORS, FORCEPS/CLAMPS, GRASPING/PULLING, CANNULATION NEEDLES, ELECTROCAUTERY INSTRUMENT, AND ANASTOMOTIC SUTURES), WHICH WERE LIKELY USED DURING A SURGICAL PROCEDURE. DISRUPTIONS IDENTIFIED WERE NOT ASSOCIATED WITH HANDLING OR MANUFACTURING PROCESS AT W.L. GORE & ASSOCIATES. IN OUR EXPERIENCE, THE NUMBER OF CANNULATIONS PRESENT, ON THREE OF THE GRAFT FRAGMENTS, IS GREATER THAN THE EXPECTED NUMBER OF CANNULATIONS FOR A 14-DAY IMPLANT. IT IS POSSIBLE THAT THE FRAGMENTS RETURNED WERE FROM MORE THAN ONE IMPLANT TIMEFRAME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH A GORE® PROPATEN® VASCULAR GRAFT FOR AV ACCESS IN THE LEFT COMMON ILIAC ARTERY. ON AN UNKNOWN DATE, DELAMINATION OF THE GRAFT WAS REPORTEDLY IDENTIFIED. ON (B)(6), THE GORE® PROPATEN® VASCULAR GRAFT WAS SURGICALLY REMOVED FROM THE PATIENT IN MULTIPLE PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636653 GORE PROPATEN VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES H060040A 6252642PP006 00733132605811

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R