BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 15326567 · Received August 31, 2022

    Report

    Report Number
    3007284313-2022-02092
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    January 12, 2022
    Report Date
    August 31, 2022
    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

    PATIENT IDENTIFIER AND WEIGHT WERE REQUESTED BUT NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CORRESPONDING AUTHOR. NO INFORMATION WAS RECEIVED. THE DEVICE REMAINS IMPLANTED. AS THE LOT # WAS NOT PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. ARTICLE CITATION: SCHULTHEISS, M., BETTINGER, D., STURM, L. ET AL. COMPARISON OF THE COVERED SELF-EXPANDABLE VIATORR CX STENT WITH THE COVERED BALLOON-EXPANDABLE BEGRAFT PERIPHERAL STENT FOR TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CREATION: A SINGLE-CENTRE RETROSPECTIVE STUDY IN PATIENTS WITH VARICEAL BLEEDING. CARDIOVASC INTERVENT RADIOL 45, 542¿549 (2022). HTTPS://DOI.ORG/10.1007/S00270-021-03040-8. AS THE DATE OF EVENT IS UNKNOWN, THE EVENT DATE USED WAS THE DATE OF ONLINE PUBLICATION, JANUARY 12, 2022. AS PATIENT IDENTIFIERS ARE UNKNOWN, THE SMARTSOLVE CASE NUMBER WAS USED FOR THE PATIENT IDENTIFIER, MEAN AGE PER ARTICLE IS 53.6, (ROUNDED UP TO 54 FOR PATIENT AGE) AND MALE USED FOR GENDER (57.5%). 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: NEW ONSET OR WORSENED ENCEPHALOPATHY. 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 "COMPARISON OF THE COVERED SELF-EXPANDABLE VIATORR CX STENT WITH THE COVERED BALLOON-EXPANDABLE BEGRAFT PERIPHERAL STENT FOR TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CREATION: A SINGLE-CENTRE RETROSPECTIVE STUDY IN PATIENTS WITH VARICEAL BLEEDING" PUBLISHED ONLINE IN CARDIOVASCULAR INTERVENTIONAL RADIOLOGY: (B)(6) 2022. THE ARTICLES PURPOSE IS TO COMPARE THE SAFETY AND EFFICACY OF THE EPTFE-COVERED SELF-EXPANSIBLE NITINOL STENT (VIATORR CONTROLLED EXPANSION, GORE, (B)(4)) WITH THE EPTFE-COVERED, BALLOON-EXPANDABLE, METALLIC STENT (BEGRAFT PERIPHERAL, BENTLEY, HECHINGEN, GERMANY) FOR THE CREATION OF THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS). THE ARTICLE REPORTS FROM SEPTEMBER 2016 TO DECEMBER 2020, 72 CONSECUTIVE PATIENTS RECEIVING TIPS FOR ACUTE VARICEAL BLEEDING (RESCUE AND EARLY TIPS, N = 15) OR FOR PROPHYLAXIS OF VARICEAL REBLEEDING (N = 57) WERE ENROLLED. FORTY PATIENTS (55.6%) RECEIVED A VIATORR CX STENT AND 32 PATIENTS (44.4%) A BEGRAFT PERIPHERAL STENT. THE TIPS IMPLANTATION WAS PERFORMED SUCCESSFULLY IN ALL PATIENTS. THE ARTICLE CONCLUDES: COMPARED TO THE PRESENT GOLD STANDARD, THE VIATORR CX STENT, THE BALLOON-EXPANDABLE BEGRAFT PERIPHERAL STENT, SHOWED SIMILAR RESULTS WITH RESPECT TO SAFETY AND EFFICACY. THE FOLLOWING PATIENT DEMOGRAPHICS FOR PATIENTS RECEIVING A VIATORR CONTROLLED EXPANSION DEVICE ARE: MEAN AGE 53.6 (ROUNDED TO 54.0) AND MALE 23/FEMALE 17. THE ARTICLE REPORTED ONE PATIENT OF THE VIATORR CX GROUP DEVELOPED SEVERE HE REQUIRING STENT REDUCTION WITHIN 30 DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468946 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| H