BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 10860905 · Received November 18, 2020

    Report

    Report Number
    3007284313-2020-01158
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    November 28, 2019
    Report Date
    November 18, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: HOSPITAL READMISSION FOLLOWING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT: A 14-YEAR. SINGLE-CENTER EXPERIENCE. CATHERINE F. VOZZO, TAVANKIT SINGH, JENNIFER BULLEN, SHASHANK SARVEPALLI, ARTHUR MCCULLOUGH, AND BALJENDRA KAPOOR. GASTROENTEROLOGY REPORT, 8(2), 2020, 98¿103. AS THE MEAN AGE IN THE STUDY WAS 56 YEARS AT THE TIME OF TIPS AND 55% OF THIS COHORT WAS MALE, THESE ARE BEING USED FOR PATIENT IDENTIFIERS. ADVANCE ACCESS PUBLICATION DATE: 28 NOVEMBER 2019, IS BEING USED AS DATE OF EVENT. 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 " HOSPITAL READMISSION FOLLOWING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT: A 14-YEAR SINGLE-CENTER EXPERIENCE " ADVANCE ACCESS PUBLICATION DATE: 28 NOVEMBER 2019. THE ARTICLES AIM IS TO IDENTIFY THE 30-DAY HOSPITAL-READMISSION RATE AFTER TIPS PLACEMENT AT OUR INSTITUTION AND TO DETERMINE POTENTIAL CAUSES AND PREDICTORS OF READMISSION. THE ARTICLE REPORTS THE AUTHORS CONDUCTED A RETROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY OF 566 PATIENTS OVER A 14 YEAR PERIOD (2004 ¿ 2017). THE ARTICLE REPORTS THAT THE 30-DAY READMISSION RATE WAS 36% (N = 202). AUTHORS LISTED CONFUSION RELATED TO HEPATIC ENCEPHALOPATHY (HE; 48%), INFECTION (15%), BLEEDING (11%), AND FLUID OVERLOAD (7%) BEING THE MOST COMMON CAUSES FOR READMISSION. AUTHORS DID NOTE THAT PATIENTS WITH A HISTORY OF HE PRIOR TO TIPS (34%) HAD A TREND FOR HIGHER READMISSION RATES THAN THOSE WITHOUT A HISTORY OF HE (41% VS 33%). AUTHORS NOTED THAT MELD SCORES AT THE TIME OF TIPS PLACEMENT WAS THE ONLY STATISTICALLY SIGNIFICANT PREDICTOR OF 30-DAY READMISSION. THE ARTICLE MENTIONS THAT PATIENTS WHO FELL WITHIN THAT 30-DAY READMISSION GROUP HAD A HIGHER PREVALENCE OF 90-DAY MORTALITY (14% VS 4%), AND NOTE THAT CERTAIN PROTECTIVE FACTORS, SUCH AS PROPHYLACTIC LACTULOSE, PROVIDER COUNSELING WITH THE PATIENT AND CAREGIVERS REGARDING EARLY SIGNS AND SYMPTOMS OF HE, AND SCHEDULING HEPATOLOGY AND ULTRASOUND FOLLOW-UPS AT DISCHARGE, COULD HELP PREVENT READMISSION AFTER TIPS PLACEMENT. AUTHORS CONCLUDE THAT ¿THE 30 -DAY READMISSION RATE AFTER TIPS PLACEMENT WITH COVERED STENTS IS HIGH, WITH NEARLY HALF OF THESE READMISSIONS DUE TO HEPATIC ENCEPHALOPATHY - A KNOWN COMPLICATION OF TIPS PLACEMENT¿, AND THAT INTERVENTIONS TO HELP REDUCE TIPS READMISSIONS SHOULD BE PRIORITIZED IN FUTURE RESEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324164 GORE VIATORR TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R