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

Model Number	PTB8106275
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the physician advanced a gore® viatorr® tips endoprosthesis to the liver.During deployment, the endoprosthesis only deployed about half-way when it was not possible to open anymore.The physician was able to pull it into the catheter and remove the device.A new device was used to complete the procedure.The patient was doing well following the procedure.
Additional Manufacturer Narrative
The engineering investigation of the returned device stated the following: - the device was returned partially constrained between the zipper and the catheter with a foreign, spiraled wire, wrapped along the distal end of the endoprosthesis and part of the delivery catheter.- the zipper pattern was evaluated for any anomalies that could contribute to a failed deployment.The loops were intact and there did not appear to be any broken fibers or other abnormalities that could prevent the zipper from deploying.- after removing the foreign wire, the device was advanced over a 0.035¿ guidewire and deployed successfully without any higher than expected deployment force.As a result of the engineering evaluation and the removal of the foreign wire from the device, the device was able to be successfully deployed.However, it is unknown if the foreign wire interfered with deployment during the case or contributed to the physician¿s observation of the endoprosthesis not being able to open any more after deploying half-way.This evaluation could not determine, with the available information, why the physician was unable to complete endoprosthesis deployment.

• 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
• MDR Report Key: 10741353
• Report Number: 3007284313-2020-01130
• Device Sequence Number: 3246122
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 05/11/2023
• Device Model Number: PTB8106275
• Device Catalogue Number: PTB8106275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 68