MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIATORR® TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Literature citation: keshava sn, moses v, sharma a, et al.Technical and medium-term clinical outcomes of transjugular intrahepatic portosystemic shunt with fluoroscopy and additional transabdominal ultrasound guidance.Indian j radiol imaging 2021; 31(04): 858-866 doi: 10.1055/s-0041-1735928 the gore® viatorr® tips endoprosthesis instructions for use list shunt stenosis or occlusion as adverse events that may occur and / or require intervention due to the tips procedure or underlying liver disease.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.

Event Description

This information was received through literature article "technical and medium-term clinical outcomes of transjugular intrahepatic portosystemic shunt with fluoroscopy and additional trans-abdominal ultrasound guidance" published online 30 november 2021 in the indian journal of radiology imaging.The article reports that occlusion of the stents was noted in 12 patients within 1 month of tips.Of the 12 stents placed, three were viatorr stent-graft (gore, flagstaff, arizona, united states), seven were niti-s (taewoong medical, seoul, south korea), and two were bare metal stents.Of the 12 patients who developed occlusion of stent within 1 month of tips, the occlusion was tackled successfully in 10 patients with angioplasty of the stent.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15452337
• MDR Text Key: 300213640
• Report Number: 3007284313-2022-02120
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male