BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 12084487 · Received June 29, 2021

    Report

    Report Number
    3007284313-2021-01486
    Event Type
    Death
    Date Received
    June 29, 2021
    Date of Event
    May 18, 2006
    Report Date
    June 29, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: HWAN-HOON CHUNG, MAHMOOD K RAZAVI, DANIEL Y SZE, JOAN K FRISOLI, STEPHEN T KEE, MICHAEL D DAKE, JEFFREY C HELLINGER AND BYUNG-CHUL KANG. PORTOSYSTEMIC PRESSURE GRADIENT DURING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT WITH VIATOR STENT GRAFT: WHAT IS THE CRITICAL LOW THRESHOLD TO AVOID MEDICALLY UNCONTROLLED LOW PRESSURE GRADIENT RELATED COMPLICATIONS? JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY 23 (2008) 95¿101. AS THE DATE OF EVENT IS UNKNOWN, THE DATE OF ACCEPTANCE FOR PUBLICATION 18 MAY 2006 WILL BE USED AS THE DATE OF EVENT. THE ARTICLE REPORTS FOR THE REPORTED DEATH AN AGE OF 51 AND MALE. THE GORE® VIATORR® TIPS ENDOPROSTHESIS INSTRUCTIONS FOR USE INCLUDES, BUT IS NOT LIMITED TO THE FOLLOWING POTENTIAL DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE: NEW ONSET OR WORSENED ENCEPHALOPATHY.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "PORTOSYSTEMIC PRESSURE GRADIENT DURING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT WITH VIATOR STENT GRAFT: WHAT IS THE CRITICAL LOW THRESHOLD TO AVOID MEDICALLY UNCONTROLLED LOW PRESSURE GRADIENT RELATED COMPLICATIONS?" PUBLISHED IN JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY 23 (2008). THE ARTICLES AIM IS TO EVALUATE THE CRITICAL LOW THRESHOLD OF PORTOSYSTEMIC PRESSURE GRADIENT (PSG) DURING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS). THE ARTICLE REPORTS SIXTY-SIX PATIENTS WITH CIRRHOSIS WHO SUCCESSFULLY UNDERWENT DE NOVO TIPS WITH VIATOR STENT GRAFTS AT STANFORD MEDICAL CENTER IN CALIFORNIA BETWEEN SEPTEMBER 2000 THROUGH JULY 2005. MEDICALLY UNCONTROLLED LOW PRESSURE GRADIENT (LPR) COMPLICATION WAS DEFINED AS WHEN A PATIENT DIED, OR WHEN ACUTE TRANSPLANTATION OR A TIPS REDUCTION PROCEDURE WAS PERFORMED DUE TO REFRACTORY ENCEPHALOPATHY OR THE DETERIORATION OF HEPATIC FUNCTION WITHIN 3 MONTHS AFTER THE PROCEDURE. ONE PATIENT DEATH WAS REPORTED WITHIN 1 WEEK FOLLOWING TIPS. CAUSE OF DEATH WAS REPORTED AS REFRACTORY HEPATIC ENCEPHALOPATHY AND REFRACTORY HEPATIC INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980289 GORE VIATORR TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death