BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 16378360 · Received February 15, 2023

    Report

    Report Number
    3007284313-2023-02345
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    July 18, 2022
    Report Date
    February 15, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: TUIFUA TS, PARTOVI S, REMER EM, RAGHEB J, BULLEN JA, KATTAN MW, KAPOOR B. ASSESSMENT OF CLINICAL OUTCOMES, CLINICAL MANIFESTATIONS, AND RISK FACTORS FOR HEPATIC INFARCTION AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PLACEMENT (TIPS): A RETROSPECTIVE COMPARATIVE STUDY. CARDIOVASC INTERVENT RADIOL. 2022 OCT;45(10):1512-1523. DOI: 10.1007/S00270-022-03219-7. EPUB 2022 JUL 18. PMID: 35851823. THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION 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: HEPATIC INFARCTION W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "ASSESSMENT OF CLINICAL OUTCOMES, CLINICAL MANIFESTATIONS, AND RISK FACTORS FOR HEPATIC INFARCTION AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PLACEMENT (TIPS): A RETROSPECTIVE COMPARATIVE STUDY" PUBLISHED ONLINE IN CARDIOVASCULAR INTERVENTIONAL RADIOLOGY: 18 JULY 2022. THE ARTICLES OBJECTIVE/AIM IS TO DESCRIBE THE IMAGING FINDINGS OF HEPATIC INFARCTION AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PLACEMENT AND IDENTIFY RISK FACTORS, CLINICAL MANIFESTATIONS, AND OUTCOMES OF INFARCTION AFTER TIPS. THE ARTICLE REPORTS THE FOLLOWING: IN THIS RETROSPECTIVE ANALYSIS OF A TIPS REGISTRY (1995¿2021), CIRRHOTIC PATIENTS WITH HEPATIC INFARCTION (N = 33) AND CONTROL PATIENTS WITHOUT INFARCT (N = 33) AFTER TIPS WERE IDENTIFIED. FOR THE CASES INCLUDED IN THIS STUDY, THE GORE VIATORR TIPS ENDOPROSTHESIS STENT-GRAFT (W.L. GORE AND ASSOCIATES, FLAGSTAFF, ARIZONA) WAS USED IN 57 PATIENTS, AND THE WALLSTENT (BOSTON SCIENTIFIC, NATICK, MASSACHUSETTS) WAS USED IN 9 PATIENTS. VIATORR (AS OPPOSED TO WALLSTENT) STENTS WERE PLACED IN 32 OF 33 PATIENTS WHO EXPERIENCED HEPATIC INFARCTION AND IN 25 OF 33 PATIENTS WITHIN THE CONTROL COHORT. HEPATIC INFARCTION INVOLVED THE RIGHT POSTERIOR SEGMENTS (SEGMENTS VI OR VII) IN 32 OF 33 PATIENTS. PRO-LONGED VASOPRESSOR REQUIREMENT (P = 0.003) AND INTENSIVE CARE UNIT STAY (P = 0.001) WERE SEEN IN PATIENTS WITH HEPATIC INFARCT, AS WELL AS TRENDS TOWARD LOWER POST-TIPS PORTOSYSTEMIC PRESSURE GRADIENT (P = 0.061) AND HIGHER RISK OF ACLF (P = 0.056). PROCEDURE-RELATED PORTAL VEIN THROMBOSIS OR HEPATIC ARTERY INJURY WAS IDENTIFIED IN 12 AND 5 PATIENTS WITH INFARCT, RESPECTIVELY. THE MEDIAN TIME FROM TIPS TO IMAGING STUDY IN THE COMBINED GROUPS WAS 8 DAYS (IQR, 2¿22 DAYS) AND WAS SIMILAR BETWEEN COHORTS (P = 0.32). MEDIAN TIME FROM TIPS TO IMAGING STUDY IN THE 33 CONTROL PATIENTS WAS 9 DAYS (IQR, 4¿22 DAYS) AFTER TIPS. THE LIVER INFARCTS DETECTED IN 33 PATIENTS WERE IDENTIFIED AT A MEDIAN OF 3 DAYS (IQR, 1¿34 DAYS) AFTER TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927030 GORE® VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| H