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

Model Number	PTB8108275
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported to gore a gore® viatorr® tips endoprosthesis was implanted during a transjugular intrahepatic portosystemic shunt (tips) procedure on (b)(6), 2022.It was reported it is unclear if a wire was used during deployment.It was reported the delivery cord broke, cause unknown.It was reported that on an unknown date, ultrasound identified a piece of catheter in the patient.On (b)(6), 2022 a tips revision took placed at which time a piece of the catheter was removed from the patient.The device remains implanted.
Additional Manufacturer Narrative
C19: a review of the manufacturing records indicate the lot met pre-release specifications.C22: device evaluation: the delivery catheter distal shaft was returned.The remainder of the delivery catheter and the endoprosthesis were not returned.The distal shaft was kinked in several locations and had frayed wire at the proximal end no other abnormalities were observed on the returned component.It was confirmed that the returned catheter component is the distal shaft of the viatorr delivery system catheter.Not enough information was provided to determine the cause of the reported event.H6: code b20 removed, added code b01.Updated code c21 to codes c19 and c22.Updated code d16 to d15.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Common Device Name: 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16883014
• Report Number: 3007284313-2023-02483
• Device Sequence Number: 12608853
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 04/05/2025
• Device Model Number: PTB8108275
• Device Catalogue Number: PTB8108275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown