BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR® TIPS ENDOPROSTHESIS

    MDR report key: 6503436 · Received April 19, 2017

    Report

    Report Number
    3007284313-2017-00097
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    September 27, 2016
    Report Date
    April 19, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED AS ITEM- AND LOT NUMBERS OF THE DEVICE WERE NOT AVAILABLE. THE ARTICLE STATED THAT THE AVERAGE OF AGE WAS 58.5 YEARS, THEREFORE 58 WAS USED AS AGE. AS GENDER WAS CHOSEN MALE, BECAUSE THE ARTICLE STATED M/F 261/128. DATE OF EVENT: THE DATE WHEN THE ARTICLE WAS PUBLISHED WAS USED AS EVENT DATE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: UNKNOWN WAS MISSED IN THE FIRST REPORT.

    Description of Event or Problem · 1

    THIS INFORMATION WAS RECEIVED THROUGH THE LITERATURE ARTICLE: ¿PROCEDURAL AND SHUNT-RELATED COMPLICATIONS AND MORTALITY OF THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPSS)¿ PUBLISHED EV PUB ONLINE 27 SEPTEMBER 2016 AP&T ALIMENTARY PHARMACOLOGY AND THERAPEUTICS. BETTINGER D., SCHULTHEISS M., BOETTLER T., MULJONO M., THIMME R., ROSSLE M.. PROCEDURAL AND SHUNT-RELATED COMPLICATIONS AND MORTALITY OF THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPSS). ALIMENTARY PHARMACOLOGY AND THERAPEUTICS. 2016; 44(10):1051-1061. THIS RETROSPECTIVE STUDY (2004 ¿ 2014) INCLUDED 389 PATIENTS IN THE STUDY COHORT. ONE HUNDRED EIGHTY FOUR PATIENTS RECEIVED A GORE® VIATORR® TIPS ENDOPROSTHESIS AND TWO HUNDRED FIVE PATIENTS A BARE STENT. DURING THE INDEX HOSPITAL STAY, PROCEDURE-RELATED COMPLICATIONS OCCURRED IN 42 PATIENTS (10.8%) WITH INTRAPERITONEAL BLEEDING IN 8 PATIENTS (2.1%) AND INFECTIONS IN 14 PATIENTS (3.6%). SHUNT- AND DISEASE-RELATED COMPLICATIONSCONSISTED OF HEPATIC ENCEPHALOPATHY IN 113 PATIENTS (1-YEAR INCIDENCE 29%), NONPROCEDURAL INFECTIONS (8.7%) AND ACUTE HEPATIC DECOMPENSATION IN 16 PATIENTS (4.1%). NINE PATIENTS (2.3%) DIED DURING THE INDEX HOSPITAL STAY FROM PROCEDURE RELATED (TWO PATIENTS, 0.5%), SHUNT-RELATED (FOUR PATIENTS, 1%) OR DISEASE RELATED CAUSES (THREE PATIENTS, 0.8%). 23 PATIENTS (5.9%) DIED DURING 4 WEEKS AFTER TIPSS IMPLANTATION. THE 1-YEAR PROBABILITY OF SURVIVAL WAS 67.7% AND WAS NEGATIVELY ASSOCIATED WITH SEVERE HEPATIC ENCEPHALOPATHYAND ACUTE HEPATIC DECOMPENSATION. SPECIFIC REPORTED COMPLICATIONS FOR PATIENTS WITH A GORE VIATORR TIPS ENDOPROSTHESIS INCLUDE: HEPATIC ENCEPHALOPATHY - 44 (23.9%); ACUTE HEPATIC DECOMPENSATION 9 (4.9%); PROCEDURE RELATED COMPLICATIONS - 21 (11.4%); INFECTIOUS COMPLICATIONS - 6 (3.3%); OTHER, INCLUDING INTRA-ABDOMINAL BLEEDING, IATROGENIC DISSECTION OF THE INFERIOR CAVA VEIN, BILIOVENOUS FISTULA, RENAL FAILURE, PULMONARY EMBOLISM, HYPOTONIA AND NAUSEA AND VOMITING - 15 (8.2%); INDEX HOSPITAL MORTALITY - 3 (1.6%); 4-WEEK MORTALITY - 8 (4.3%). THERE WAS NO EFFECT OF THE STENT TYPE ON THE DEVELOPMENT OF POST-TIPSS HEPATIC ENCEPHALOPATHY, ACUTE HEPATIC DECOMPENSATION AND PROCEDURE-RELATED COMPLICATIONS. THE CONCLUSIONS FOR THIS STUDY: EXCEPT HEPATIC ENCEPHALOPATHY, SEVERE PROCEDURE- AND SHUNT-RELATED COMPLICATIONS ARE RARE AND EARLY MORTALITY IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285529 GORE VIATORR® TIPS ENDOPROSTHESIS SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R