BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS - 3

    MDR report key: 8417242 · Received March 13, 2019

    Report

    Report Number
    2017233-2019-00139
    Event Type
    Death
    Date Received
    March 13, 2019
    Date of Event
    February 15, 2019
    Report Date
    April 1, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF THE RETURNED DEVICE REVEALED THE FOLLOWING: THE DISTAL SHAFT UPON WHICH THE ENDOPROSTHESIS WAS MOUNTED WAS BROKEN AT THE TRANSITION. THE DISTAL SHAFT-TRANSITION BOND DID NOT APPEAR TO BE COMPROMISED. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM, A RIGHT COMMON ILIAC ARTERY ANEURYSM AND A RIGHT INTERNAL ILIAC ARTERY ANEURYSM USING THE GORE® EXCLUDER® AAA ENDOPROSTHESES, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN). THE VIABAHN WAS PLANNED TO BE PLACED IN THE SUPERIOR GLUTEAL ARTERY. DURING ADVANCEMENT OF THE VIABAHN, VIA A 12FR SHEATH, A KINK WAS OBSERVED IN THE CATHETER SHAFT WHERE THE DISTAL END OF THE STENT GRAFT WAS POSITIONED. THE DOCTOR REPORTED THE KINK PROBABLY OCCURRED AS A RESULT OF MANIPULATION INSIDE THE PATIENT. THE DOCTOR DECIDED TO REMOVE THE VIABAHN AND ATTEMPTED TO RETRACT THE DELIVERY SYSTEM BUT THE KINKED PORTION CAUGHT THE HUB OF THE SHEATH RESULTING IN DEVICE SEPARATION CLOSE TO THE PUNCTURE SITE. THE ENTIRE DELIVERY SYSTEM WAS RETRACTED ALONG WITH THE SHEATH FROM THE PATIENT. THE SEPARATED PORTION WAS RETRACTED WITH FORCEPS. THE DOCTOR ALSO REPORTED THAT THE FLUOROSCOPE BROKE DOWN AND HAD TO BE REPLACED DURING THE PROCEDURE EXTENDING THE OVERALL PROCEDURE TIME. A 12FR SHEATH WAS ADVANCED AND ANOTHER VIABAHN WAS SUCCESSFULLY PLACED IN THE TARGET LESION. ACCORDING TO THE DOCTOR, THE PATIENT TOLERATED THE PROCEDURE. SIX DAYS LATER THE PATIENT EXPIRED AS A RESULT OF LOWER LIMB ISCHEMIA, REPERFUSION INJURY, AND MULTIPLE ORGAN FAILURE. THE DOCTOR SUGGESTED THAT THE PROLONGED PROCEDURE TIME WAS A CONTRIBUTING FACTOR ALSO.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE DEVICE WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: A KINK OF THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) DELIVERY SYSTEM OCCURRED DURING MANIPULATION OF THE CATHETER IN THE PATIENT¿S TORTUOUS ANATOMY. THE DOCTOR REPORTED THAT WITH GREAT EFFORT THE LEFT ILIAC ARTERY WAS COIL EMBOLIZED. ADDITIONALLY, DURING THE PROCEDURE THE FLUOROSCOPE BROKE DOWN AND WAS REPLACED WITH ANOTHER FLUOROSCOPE. ACCORDING TO THE DOCTOR, THE PROLONGED PROCEDURE TIME CONTRIBUTED TO LOWER LIMB ISCHEMIA, REPERFUSION INJURY, AND MULTIPLE ORGAN FAILURE. AS A RESULT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210431 GORE VIABAHN® ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES 15682494

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death