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

Catalog Number	PTB8106275
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the physician selected a gore® viatorr® tips endoprosthesis with controlled expansion (viatorr®) for a transjugular intrahepatic portosystemic shunt procedure.During the procedure the device failed to deploy.Reportedly, the uncovered portion of the device was uncovered from the sheath, and when the deployment string was pulled, the device bowed with tension and would not deploy.It appeared the wire was kinked and had possibly lost some of its strength.An amplatzer guidewire was used, size not known.The sheath information is unknown.Another viatorr® of the same size was used to complete the procedure, which the patient tolerated.
Additional Manufacturer Narrative
The device was returned for engineering analysis with the delivery system contained within the introducer sheath and the endoprosthesis partially deployed.The zipper was slightly bunched for the most distal knot rows, but no abnormalities were noted that would prevent deployment.Engineering attempted to deploy the remainder of the device, and the device successfully deployed.Not enough information was provided to determine the cause of the event.The gore® viatorr® tips endoprosthesis with controlled expansion instructions for use (ifu) warns: ¿ inadvertent, partial, or failed deployment of the device or device migration may require surgical intervention.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.

• 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: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20239614
• Report Number: 3007284313-2024-03486
• Device Sequence Number: 12989848
• Product Code: MIR
• UDI-Device Identifier: 00733132635023
• UDI-Public: 00733132635023
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2026
• Device Catalogue Number: PTB8106275
• 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: 07/25/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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