BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 14274269 · Received May 4, 2022

    Report

    Report Number
    2017233-2022-02896
    Event Type
    Death
    Date Received
    May 4, 2022
    Date of Event
    April 22, 2022
    Report Date
    August 4, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132646081
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. MANUFACTURING RECORDS WERE REVIEWED, AND THE DEVICE MET ALL PRE-RELEASE SPECIFICATIONS. THE REPORTED DEPLOYMENT DIFFICULTY WITH A BROKEN DEPLOYMENT LINE WAS CONFIRMED THROUGH EVALUATION OF THE IMAGES PROVIDED. THE INVESTIGATION COULD NOT CONFIRM THE CAUSE OF THE REPORTED HAZARDOUS SITUATION NOR THE PRIMARY DEVICE FAILURE MODE WITH THE AVAILABLE INFORMATION, INCLUDING EVALUATION OF PROVIDED IMAGES. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON EVALUATION OF THE IMAGES PROVIDED AND THE INFORMATION REPORTED TO GORE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED TO GORE: ON (B)(6) 2022, A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX DEVICE) WAS INTENDED FOR USE IN THE POPLITEAL ARTERY FOR TREATMENT OF AN ANEURYSM. AFTER AN 11MM X 10CM VSX DEVICE WAS SUCCESSFULLY IMPLANTED, AN ADDITIONAL 11MM X 5CM VSX DEVICE WAS TO BE IMPLANTED AT THE DISTAL END OF THE FIRST DEVICE. REPORTEDLY THE DEPLOYMENT LINE WAS DIFFICULT TO PULL AND AFTER A FEW ATTEMPTS THE DEPLOYMENT LINE CAME OUT. HOWEVER, AFTER AN ANGIOGRAM WAS PERFORMED, IT WAS OBSERVED THE DEPLOYMENT LINE BROKE AND APPROXIMATELY HALF THE VSX DEVICE REMAINED CONSTRAINED. THE DELIVERY CATHETER WAS PULLED TO THE INTRODUCER SHEATH AND THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH AND CATHETER IN TANDEM BY PULLING UP AND OVER THE AORTIC BIFURCATION. HOWEVER, THE VSX DEVICE HAD BECOME STUCK AT THE INCISION SITE AND A CUT DOWN WAS PERFORMED TO REMOVED THE VSX DEVICE. AFTER THE VSX DEVICE WAS REMOVED AND THE FINAL SUTURES WERE 3 BEING PLACED, THE PATIENTS VITALS DROPPED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU) AND PLACED ON A VENTILATOR. IT WAS REPORTED THAT THE PATIENTS FAMILY TOOK HIM OFF OF LIFE SUPPORT AND THE PATIENT EXPIRED. THE PHYSICIAN SUSPECTED: THE PATIENT DIDN'T EXPIRE DUE TO DEVICE FAILURE OR BLOOD LOSS. IT WAS DUE TO ADDITIONAL ANESTHESIA DOSING FOR DEVICE REMOVAL. NOTED: BOTH DEVICES HAD DIFFICULTIES ADVANCING THROUGH A 10FR X 45CM ANSEL SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318009 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. VBHR110502A 00733132646081

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death| H