BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 19291816 · Received May 10, 2024

    Report

    Report Number
    3007284313-2024-03217
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    February 17, 2024
    Report Date
    May 10, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    YU, Q. ET AL. (2024) ¿ENDOVASCULAR RETRIEVAL OF A DAMAGED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT STENT GRAFT,¿ JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY [PREPRINT]. ENDOVASCULAR RETRIEVAL OF A DAMAGED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT STENT GRAFT DOI: 10.1016/J.JVIR.2024.02.018. 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: SHUNT STENOSIS OR OCCLUSION 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

    YU, Q. ET AL. (2024) ¿ENDOVASCULAR RETRIEVAL OF A DAMAGED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT STENT GRAFT,¿ JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY [PREPRINT]. ENDOVASCULAR RETRIEVAL OF A DAMAGED TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT STENT GRAFT DOI: 10.1016/J.JVIR.2024.02.018. THIS IS A CASE REPORT DESCRIBING TREATMENT OF A 39-YEAR-OLD MALE PATIENT WITH CIRRHOSIS AND RECURRENT ASCITES WHO UNDERWENT TIPS PLACEMENT AT AN OUTSIDE FACILITY. THE CRANIAL END OF THE INITIAL VIATORR STENT GRAFT DEPLOYED FROM THE RIGHT PORTAL VEIN (PV) TO THE RIGHT HEPATIC VEIN LANDED WITHIN THE INTRAHEPATIC PARENCHYMA. SUBSEQUENT TIPS REVISION ON THE SECOND DAY VIA DE NOVO RIJ VEIN ACCESS REVEALED EARLY OCCLUSION OF THE INITIALLY PLACED VIATORR STENT. BALLOON ANGIOPLASTY FOLLOWED BY CRANIAL EXTENSION OF THE EXISTING SHUNT WITH BARE-METAL STENTS RESULTED IN BRISK ANTEGRADE FLOW AND GRADIENT REDUCTION FROM 13 MM HG TO 7 MM HG. FOLLOW-UP ULTRASOUND (US) CONFIRMED PATENCY. THE PATIENT¿S POSTPROCEDURAL HOSPITALIZATION COURSE WAS UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904400 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention| H