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 Codes	Device Slipped (1584); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician selected a gore® viatorr® tips endoprosthesis with controlled expansion for a transjugular intrahepatic portosystemic shunt procedure.It was further reported that the introducer sheath had moved and when the sheath was pulled off the stent, the chainlink portion of the device deployed in the hepatic vein.The physician was unable to retrieve the device into the introducer sheath and a vascular surgeon was called to remove the device via a cut down in the jugular vein.A wallstent was then used to complete the procedure, and there were no reported adverse effects to the patient.
Additional Manufacturer Narrative
Additional information received and the following sections have been updated accordingly: section b5 - 'description of event'.Section h6 - 'medical device problem' code.Section h6 - 'investigation conclusions' code.
Event or Problem Description
It was reported the physician selected a gore® viatorr® tips endoprosthesis with controlled expansion for a transjugular intrahepatic portosystemic shunt procedure.It was further reported that the introducer sheath had moved into the hepatic vein, and the physician unintentionally deployed the chain link when unsheathing.The physician was unable to retrieve the device into the introducer sheath and a vascular surgeon was called to remove the device via a cut down in the jugular vein.A wallstent was then used to complete the procedure, and there were no reported adverse effects to the patient.

• 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: 11820782
• Report Number: 3007284313-2021-01426
• Device Sequence Number: 3747589
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 05/18/2021

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: 02/21/2022
• Device Model Number: PTB8108275
• Device Catalogue Number: PTB8108275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR