BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    MDR report key: 16936960 · Received May 16, 2023

    Report

    Report Number
    3007284313-2023-02499
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 17, 2023
    Report Date
    December 18, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS REQUESTED FROM THE PHYSICIAN, BUT NOTHING WAS PROVIDED. THE PHYSICIAN BELIEVES THAT THE EVENT IS DISEASE-RELATED. WITH THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    A SERIAL- / LOT NUMBER WAS MADE AVAILABLE. PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOTS MET PRE-RELEASE SPECIFICATIONS. WITH THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    IN THE IFU FOR THE GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION THE FOLLOWING IS STATED: ADVERSE EVENTS. POTENTIAL CLINICAL AND DEVICE ADVERSE EVENTS: POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION OR IN ANY TIPS PROCEDURE AND REQUIRE INTERVENTION MAY INCLUDE, BUT ARE NOT LIMITED TO: NEW ONSET OR WORSENED HEPATIC ENCEPHALOPATHY.

    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: REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. 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. FURTHER DETAILS WERE REQUESTED FROM THE PHYSICIAN, BUT NOT PROVIDED YET. 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 GRADE III. 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 IS A RECURRENCE OF A PRE-EXISTING PORTAL HYPERTENSION COMPLICATION, WHICH REQUIRED HOSPITAL READMISSION ON (B)(6) 2023. THE EVENT REQUIRED TREATMENT; IN THIS CASE THE TYPE OF TREATMENT WAS MEDICATION. THE RESOLUTION DATE WAS (B)(6) 2023. FURTHERMORE THERE HAVE BEEN RECURRING INCIDENCE OF HE WITHIN THE 30 DAYS THAT ARE BEING MEDICALLY MANAGED, AND THAT IT IS BELIEVED TO BE DISEASE-RELATED PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475628 GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| O