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

Catalog Number	PTB8108275
Medical Device Problem Codes	Separation Failure (2547); Activation Problem (4042)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the physician was implanting a gore® viatorr® tips endoprosthesis with controlled expansion.During deployment, the covered portion of the stent only partially expanded and then the deployment cord would not pull any more.When the physician pulled harder, the cord broke.A high-pressure balloon was used to try to finish expansion of the stent but was unsuccessful.The case was aborted, with the patient in stable condition.
Additional Manufacturer Narrative
The engineering investigation of the returned catheter stated the following: - the delivery system was returned for analysis.- the deployment line was approximately 98 cm long.- the end of the deployment line was put under magnification.No clean cuts were observed.The physician¿s observations that the deployment line broke was confirmed.With the available information, it could not be determined why the deployment line broke.Not enough information was provided to determine the cause of the reported event.A4: no patient weight.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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19297993
• Report Number: 3007284313-2024-03224
• Device Sequence Number: 6865162
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/13/2024

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: 09/21/2026
• Device Catalogue Number: PTB8108275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Male