MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABIL® SHORT WIRE BILIARY ENDOPROSTHESIS; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number	VSWVH1008
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device examination could not be performed.A review of the manufacturing records for lot 31344963 was completed and confirmed the lot met all pre-release specifications.One nonconformance (b)(4) associated with the lot was identified during product history review; however, the investigation determined the issue was limited to documentation traceability and was not related to product quality or device performance.Additional information was requested from the distributor and user facility regarding the event, patient outcome, procedural details, and device condition; however, no additional information was provided.Based on the available information, the reported event could not be confirmed and a definitive root cause could not be determined.The relationship, if any, between the reported device shredding during removal and the reported patient bleeding could not be conclusively established.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 or Problem Description
It was reported by olympus that a gore® viabil® short wire biliary endoprosthesis was selected for use during an endoscopic retrograde cholangiopancreatography (ercp) procedure.During withdrawal of the device, material damage described as shredding was observed.Following the event, the patient experienced bleeding requiring intubation and transfer to the intensive care unit (icu).Additional information regarding the procedure, reason for device removal, device condition, treatment of the bleeding, and patient outcome was requested but was not available at the time of this report.

• Brand Name: GORE® VIABIL® SHORT WIRE 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 1408
• Manufacturer Contact: megan reigh ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25861058
• Report Number: 3003910212-2026-01665
• Device Sequence Number: 20223531
• Product Code: FGE
• UDI-Device Identifier: 00733132638802
• UDI-Public: (01)00733132638802(17)281116
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VSWVH1008
• 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: 06/29/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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: Life Threatening; Hospitalization
• Patient Sex: Unknown