MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC, METALLIC, EXPANDABLE

Model Number	G48038
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Upon normal opening of the package, the stent was introduced along the wire guide.However, upon reaching the stenosis area, resistance was encountered just as it was about to reach the turning point, making it difficult to advance the stent delivery system.After several attempts, it was unsuccessful.Upon retraction of the stent delivery system, two kinks were observed on the stent sheath.Concerned about potential accidents if the stent was continued to be used, a new stent was substituted to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Are there any clinical imaging/videos available? no.Was the product inspected for damage before use? (kinks etc) no.Details of the wire guide used (diameter, type, make)? 0.035'' wire guide.Did the patient exhibit difficult anatomy? no.Was the stricture dilated before stent placement? no.Was an assessment carried out to determine the necessity for pre-dilation? no dilation.Was resistance encountered when advancing the wire guide to the target location? yes.Was the directional button pressed during use? no.Was the yellow marker kept in view during attempted deployment? yes.Did any part of the stent contact the patient's anatomy when the complaint occurred? yes.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G., kink)? kink.
Additional Manufacturer Narrative
E1 - phone: (b)(6).E1 - email: (b)(6).Device received but remains under investigation.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: MQR STENT, COLONIC, METALLIC, EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 25152445
• Report Number: 3001845648-2026-00172
• Device Sequence Number: 9351928
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)271218(10)C2378849
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K163468
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C2378849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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
• Patient Sex: Female