BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 9764624 · Received February 27, 2020

    Report

    Report Number
    2017233-2020-00132
    Event Type
    Death
    Date Received
    February 27, 2020
    Date of Event
    January 14, 2020
    Report Date
    July 30, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    UDI-DI
    00733132605873
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: NAME (#1) - CBAS® HEPARIN SURFACE. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #6299684PP033. 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

    THE FOLLOWING ENGINEERING EVALUATION WAS PERFORMED WITH NO DEVICES RETURNED TO W.L. GORE & ASSOCIATES: TWO DEVICE SERIAL NUMBERS ASSOCIATED WITH THIS EVENT WERE PROVIDED, BUT THE IDENTITY OF THE ASSOCIATED DEVICES COULD NOT BE CONFIRMED. MD142775, GORE-TEX® VASCULAR GRAFT AND GORE® PROPATEN® VASCULAR GRAFT PROCESS FAILURE MODES AND EFFECTS ANALYSIS (PFMEA), REVISION 9 WAS REVIEWED FOR PROCESS STEPS WITH SUTURE LINE DISRUPTION AS A POTENTIAL DEVICE FAILURE MODE OR OCCLUSION AS A POTENTIAL HAZARDOUS SITUATION. PROCESS STEPS IDENTIFIED SPAN THE COMPONENT/KITTING PROCESSES IN MEDICAL WEST, THE HEPARIN COATINGS/CUTTING/PACKAGING PROCESSES IN KENDRICK PEAK, AND THE BOXING PROCESS IN FISHER POINT. ALL DEVICE HISTORY RECORDS ASSOCIATED WITH BOTH DEVICE SERIAL NUMBERS WERE REVIEWED ACROSS ALL AFOREMENTIONED PROCESSES. ALL APPROPRIATE SIGNATURES AND OTHER EVIDENCE OF PROCESS CONFORMATION WERE VERIFIED. THE EVENT DESCRIPTION COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. THE REPORTED CODES REFLECT THE EVENT DESCRIPTION, BUT CANNOT BE CONFIRMED. ADDITIONAL DEVICES INCLUDED ON THIS REPORT ARE AS FOLLOWS: ITEM # HT087080A/ LOT # 5918388PP019, WHICH IS CAPTURED IN MANUFACTURER REPORT # 2017233-2020-00082.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - UPDATED TO (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR AN ENGINEERING EVALUATION. 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. 2 DEVICES WERE REPORTED TO GORE. REFERENCE MEDWATCH 2017233-2020-00082 FOR SECOND DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 AN 8MM GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED AS A BYPASS, COMMON ILIAC TO DISTAL SFA. ON (B)(6) 2020 THE PHYSICIAN PERFORMED A RE-EXPLORATION AS A RESULT OF AN IDENTIFIED OCCLUSION WITHIN THE GRAFT. THE DOCTOR PERFORMED A GRAFT THROMBECTOMY AS WELL AS REVISION OF THE DISTAL ANASTOMOSIS, EXTENDING TREATMENT BY SEWING A SECOND GRAFT TO THE DISTAL ANASTOMOSIS TO THE POPLITEAL BELOW KNEE POSITION. ON (B)(6) THE GRAFT TO GRAFT ANASTOMOSIS DISRUPTED. ACCORDING TO THE DOCTOR, THE PATIENT BLED OUT VERY RAPIDLY AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227142 GORE PROPATEN VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES H080040A 6299684PP033 00733132605873

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death