MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE VIABIL BILIARY ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	VSWVN1004
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The stent would not deploy correctly.

• Brand Name: GORE VIABIL BILIARY ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86004
• MDR Report Key: 19115030
• Report Number: 19115030
• Device Sequence Number: 7140963
• Product Code: FGE
• UDI-Device Identifier: 00733132638857
• UDI-Public: (01)00733132638857(17)260730
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024
• Report Date (Section F): 01/23/2024

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: Other
• Device Model Number: VSWVN1004
• Device Catalogue Number: VSWVN1004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Date Report Sent to FDA: 01/23/2024