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	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During expansion, something cracked in the handle and the prosthesis did not open.After starting to expand the stent using the trigger, a cracking sound was heard and the stent stopped responding to the trigger.Is the complaint device available for return to cirl? if so, please provide tracking number details.Yes, dhl (b)(4).Are there any images/videos of the complaint device/procedure available? no.What endoscope type and channel size was used? pentax 4.2 mm.What was the target location? sigmoid colon.What was the diameter of the wire guide used? cook medical-metii-35-480.Was the zip port facing upwards and slightly curved when backloading the wire guide? yes.Did the patient exhibit difficult anatomy (n/a, tortuous, altered)? no.Was pre-dilation/post-dilation performed? no.Was resistance encountered when advancing the delivery system to the target location? (if resistance was felt how did the physician deal with the resistance encountered?) no resistance.Was resistance encountered when advancing the delivery system to the target location? (if resistance was felt how did the physician deal with the resistance encountered?) none.Was a stent previously placed at the same or adjacent location? (if yes, was the complaint stent placed in the stent that/was already in situ?) no.What was the position of the elevator during advancement/deployment/removal? open.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? no how was the procedure completed? (ie.Another device, scheduled for another day) another stent was used.

• 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 rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 24779596
• Report Number: 3001845648-2026-00123
• Device Sequence Number: 6064340
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)260806(10)C2201150
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 05/19/2026

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 Expiration Date: 08/06/2026
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C2201150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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: Male