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

Catalog Number PT8107275K

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Engineering evaluation: a picture, video and delivery catheter were provided for analysis.In the provided picture, the covered portion of the device is partially deployed with the physician pulling on the deployment line.The video shows a similar status of the device and as the video plays, the physician has difficulty with continuing the deployment of the covered portion of the device.Evaluation of the delivery catheter was performed as the device was returned deployed without an endoprosthesis.A break in the deployment line was observed approximately 200 mm from the proximal bump.Not enough information was provided to determine the cause of the reported event.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

During a catheter angioplasty, through a transjugular intrahepatic portosystemic shunt (tips) using a gore® viatorr® tips endoprosthesis with controlled expansion, it was not possible to properly release the stent as the release system was damaged.The damaged material was removed through transjugular access with an angiographic introducer.A second gore® viatorr® tips endoprosthesis with controlled expansion was used.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17607648
• MDR Text Key: 321816554
• Report Number: 3007284313-2023-02718
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PT8107275K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male