BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 15683354 · Received October 27, 2022

    Report

    Report Number
    3007284313-2022-02173
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    March 22, 2022
    Report Date
    October 27, 2022
    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

    CITATION: MCDANIEL C, BELL R, FARHA N, ET AL. RISK OF HERNIA- RELATED COMPLICATIONS AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION IN PATIENTS WITH PRE- EXISTING VENTRAL ABDOMINAL HERNIAS: 15- YEAR EXPERIENCE AT A QUATERNARY MEDICAL CENTER. BMJ OPEN GASTRO 2022;9:E000876. DOI:10.1136/BMJGAST-2022-000876. 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 "RISK OF HERNIA-RELATED COMPLICATIONS AFTER TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT CREATION IN PATIENTS WITH PRE-EXISTING VENTRAL ABDOMINAL HERNIAS: 15-YEAR EXPERIENCE AT A QUATERNARY MEDICAL CENTER" PUBLISHED ONLINE IN BMJ OPEN GASTROENTEROLOGY ON MARCH 22, 2022. THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WITH PRE-EXISTING ABDOMINAL HERNIAS WHO UNDERWENT PRIMARY TIPS PLACEMENT WITH GORE® VIATORR® TIPS ENDOPROSTHESES BETWEEN 2004 AND 2018. A TOTAL OF 167 PATIENTS WITH PRE- EXISTING ASYMPTOMATIC ABDOMINAL HERNIAS WERE INCLUDED IN THE ANALYSIS. A TOTAL OF 36 PATIENTS (21.6%) DEVELOPED HERNIA-RELATED COMPLICATIONS AFTER TIPS PLACEMENT, INCLUDING 20 PATIENTS WITH ACUTE COMPLICATIONS AND 16 WITH NON-ACUTE COMPLICATIONS. THE MEAN TIME TO PRESENTATION OF HERNIA- RELATED COMPLICATIONS WAS 66 DAYS. OF PATIENTS WITH ACUTE COMPLICATIONS, 78.9% REQUIRED EMERGENT SURGICAL REPAIR AND 15.8% UNDERWENT ELECTIVE SURGICAL REPAIR. OF THOSE WITH NON-ACUTE COMPLICATIONS, ALL UNDERWENT ELECTIVE SURGICAL REPAIR. 2203-A:-OTHER (PRE-EXISTING HERNIA COMPLICATIONS POST-TIPS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720741 GORE® VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention