BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 17823148 · Received September 27, 2023

    Report

    Report Number
    3007284313-2023-02773
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    September 2, 2023
    Report Date
    September 27, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT IDENTIFIER REFLECTS THE STUDY NUMBER WITH CODES FOR THE HOSPITAL AND PATIENT. H3: OTHER: ENGINEERING EVALUATION COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED. H6 EVALUATION CODES MEDICAL DEVICE PROBLEM CODE A27 WAS USED FOR HEPATIC ENCEPHALOPATHY WITH HOSPITALIZATION WITHIN 30 DAYS. H6 EVALUATION CODES INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET PRE-RELEASE SPECIFICATIONS. THE PHYSICIAN STATED THAT THE EVENT IS STUDY-PROCEDURE-RELATED. 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

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION (TIPS) WITH A GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VIATORR-DEVICE) ON (B)(6) 2023, BECAUSE OF ASCITES AND A PORTAL VEIN THROMBOSIS. A GORE TIPS SET WAS USED, AND THEY WERE ABLE TO PUNCTURE ACROSS THE LIVER TISSUE (HEPATIC PARENCHYMA) TO ACCESS THE PORTAL VEIN FROM THE HEPATIC VEIN. THE DEVICE WAS SUCCESSFULLY DELIVERED AND DEPLOYED TO CREATE AN INTRAHEPATIC SHUNT CONNECTION. NO ADJUNCTIVE PROCEDURES WERE PERFORMED. ON (B)(6) 2023, THE PATIENT PRESENTED HEPATIC ENCEPHALOPATHY (HE) WHICH REQUIRED HOSPITAL READMISSION AND TREATMENT; IN THIS CASE THE TYPE OF TREATMENT WAS MEDICATION. THE ADVERSE EVENT WAS RECOVERED / RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023. THE PHYSICIAN STATED THAT THE EVENT IS STUDY-PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096912 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention GORE TIPS SET