MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® VIABIL® Biliary Endoprosthesis; Stents, Drains And Dilators For The Biliary Ducts

Catalog Number	VH1008040
Medical Device Problem Codes	Obstruction of Flow (2423); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Obstruction/Occlusion (2422)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: GORE® VIABIL® Biliary Endoprosthesis
• Common Device Name: Stents, Drains And Dilators For The Biliary Ducts
• Manufacturer (Section D): W. L. Gore & Associates, Inc.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 -140
• Manufacturer Contact: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50872655
• Report Number: 3003910212-2026-01671
• Device Sequence Number: 13106410
• Product Code: FGE
• UDI-Device Identifier: 00733132615490
• UDI-Public: (01)00733132615490(17)290224
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VH1008040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Female