MAUDE Adverse Event Report: Cook Ireland Ltd SOLUS BILIARY STENT AND INTRODUCER SET; FGE stents, drains and dilators for the biliary ducts

Model Number	G25671
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event: the doctor is an experienced user of this product line, so user error has been completely ruled out.This doctor has encountered two cases where the stent spontaneously migrated and was expelled via the gi tract in less than one month post-placement.During placement, the stent was anchored deeply into the ihd.Although the product feature and indication specify a dwell time of up to 6 months, these stents migrated within just 1 month.The physician noted that migration never occurred with the previously used zimmon stents.However, two of these double pigtail stents migrated within one month.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: SOLUS BILIARY STENT AND INTRODUCER SET
• Common Device Name: FGE stents, drains and dilators for the biliary ducts
• Manufacturer (Section D): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer (Section G): Cook Ireland Ltd; o'halloran rd; national technology park; limerick V94 N 8X2; EI V94 N8X2
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick V94 N-8X2 ; EI V94 N8X2 ; +353()061334440
• MDR Report Key: 50272680
• Report Number: 3001845648-2026-00329
• Device Sequence Number: 10316213
• Product Code: FGE
• UDI-Device Identifier: 10827002256719
• UDI-Public: (01)10827002256719(17)281021(10)C2357864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: Health Professional
• Device Model Number: G25671
• Device Catalogue Number: ZSS-10-4-RB
• Device Lot Number: C2357864
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 151 LB