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

Catalog Number PT8108275

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Encephalopathy (1833)

Event Date 01/14/2024

Event Type  Injury  

Manufacturer Narrative

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: engineering evaluation could not be performed as the device remains implanted.H6: evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the lots met pre-release specifications.As primary relationship disease related is mentioned in the study database.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

The following was reported to gore on 1/30/2024 from a study: on (b)(6) 2024, this 84-year-old patient underwent tips procedure for ascites.The patient was treated with a gore® viatorr® tips endoprosthesis with controlled expansion device to the portal vein.The study device was successfully delivered during the procedure.On (b)(6) 2024, it was noted the patient developed hepatic encephalopathy grade ii after tips which required hospital readmission and treatment.Inpatient or prolonged hospitalization was required and the type of treatment was medication.The adverse event was recovered / resolved without sequelae and the patient discharged on (b)(6) 2024.

Manufacturer Narrative

Neither clinical images enabling direct assessment of product performance nor the device was returned for evaluation.With the available information, we are unable to determine the cause of this incident and assign a root cause.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.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18719052
• MDR Text Key: 335524136
• Report Number: 3007284313-2024-03052
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PT8108275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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: 84 YR
• Patient Sex: Female
• Patient Weight: 81 KG