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

Model Number	PTB8107275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Encephalopathy (1833)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® viatorr® tips endoprosthesis with controlled expansion instructions for use states: adverse events associated with the use of the device may include, but are not limited to: new onset or worsened encephalopathy.
Event or Problem Description
It was reported to gore a gore® viatorr® tips endoprosthesis with controlled expansion was implanted (b)(6) 2020 during a transjugular intrahepatic portosystemic shunt (tips) procedure.A revision procedure using a gore® viatorr® tips endoprosthesis with controlled expansion was performed on (b)(6) 2020 in an attempt to narrow the tips lumen due to persistent hepatic encephalopathy.It was reported that the gore® viatorr® tips endoprosthesis with controlled expansion stent that was previously placed had been dilated to 10mm when placed.The physician performing the revision procedure deployed the gore® viatorr® tips endoprosthesis with controlled expansion in the expectation that it would only expand to 8mm, however; the stent deployed to 9.8mm and did not produce the narrowed lumen that was desired for the procedure.The physician was successful in reducing the diameter of the tips after placing a third gore® viatorr® tips endoprosthesis with controlled expansion with a balloon expandable stent between it and the second one.The patient did well clinically.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Common Device Name: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10028495
• Report Number: 3007284313-2020-00124
• Device Sequence Number: 3776033
• Product Code: MIR
• UDI-Device Identifier: 00733132635030
• UDI-Public: 00733132635030
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2022
• Device Model Number: PTB8107275
• Device Catalogue Number: PTB8107275
• Device Lot Number: 21401223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 96