MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO,STENT, ILIAC

Model Number	G61178
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
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
Customer deployed a zilver flex stent (b)(6) 2026) that elongated in the patient.Stent remained in patient, doctor post dilated with on.035 balloon.No issues with blood flow and no issue with the patient.No addition procedures necessary.The following information has been received via email on 24-apr-2026.What was the date of the occurrence? (b)(6) 2026.Is the device available for return? no please provide details on what type of procedure was performed.Sfa stenting.Details of access sheath used (name, fr size, length)? cook ansel unsure of fr size.What was the target location for the stent? l sfa.What disease pathology was being treated? plaque.Was the device used percutaneously? n/a was pre-dilation performed ahead of placement of the stent? no what was the access site chosen? pedal was a stent previously placed during previous procedures? yes did the patient exhibit difficult anatomy? no what intervention (if any) was required? none was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? none was needed were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G., kink)? not according to dr or scrub nurse was there evidence of post deployment stent compress or deformation? yes was the delivery system able to be advanced to the target site easily/with no resistance? yes was post dilation performed after the placement of the stent? yes was the stent fully deployed from the delivery system prior to removal of device? no 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?) neither previous stent was in the illiac.Was the stent being placed through the side wall of a previously placed stent? no.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO,STENT, ILIAC
• 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: 25139544
• Report Number: 3001845648-2026-00171
• Device Sequence Number: 15831727
• Product Code: NIO
• UDI-Device Identifier: 10827002611785
• UDI-Public: (01)10827002611785(17)281106(10)C2363065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050017/S006
• 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: G61178
• Device Catalogue Number: ZFV6-35-125-6-200
• Device Lot Number: C2363065
• Was Device Available for Evaluation?: No
• 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: 05/11/2026
• Supplement Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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: Unknown