GORE® VIABIL® Short Wire Biliary Endoprosthesis

Description of Event or Problem

Gore received a Voluntary MedWatch (MDR Report #MW5189674) regarding the GORE® VIABIL® Short Wire Biliary Endoprosthesis. The report stated the following:The hospital was notified by their Olympus representative that Gore had issued a recall of a certain size GORE® VIABIL® Biliary Endoprosthesis stent. One of the stents included in this recall was implanted in a patient on (b)(6) 2026. The physician and risk management team spoke with the patient regarding the recall and the physician's planned course of action due to the incorrect stent size being implanted.The physician believes that the shorter stent length poses a long-term risk of dislodgement or migration. To optimize long-term outcomes, the physician has determined that an additional stent will be placed within the current stent. This approach is intended to ensure appropriate expansion of the stent waist and minimize the risk of stent mispositioning.This complaint is associated with (b)(4).

Additional Manufacturer Narrative

Gore received a Voluntary MedWatch (MDR Report #MW5189674) regarding the GORE® VIABIL® Short Wire Biliary Endoprosthesis.A1: No patient specific details have been provided. Therefore, the patient initials reflect the W.L. Gore internal case number.A2 - A4: age, gender, and weight were requested, but not provided.H6 - Code B13: Additional information regarding the event was requested from the complainant, but no response was received.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.