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

Model Number	G18282
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During stent deployment, the physician obtained retrograde tibi-peroneal access and attempted to extend the stent into hunter¿s canal.The physician stated ¿felt like the stent wasn't fully opening".A guidewire could not be advanced through the newly placed stent, although imaging suggested it was open.Multiple attempts were made to cross the stent, including the use of a balloon, without success.Pushing the stent resulted in deformation, causing the stent to collapse/crush into itself.The procedure was discontinued, and a second procedure was scheduled for two weeks later [(b)(6) 2026].Details of access sheath used (name, fr size, length)? - 6fr terumo slender what was the target location for the stent? - sfa (superficial femoral artery) was the device used percutaneously? - yes was pre-dilation performed ahead of placement of the stent? - yes what was the access site chosen? - common femoral artery with retrograde was a stent previously placed during previous procedures? - no did the patient exhibit difficult anatomy? - heavily calcified was the approach ipsilateral or contralateral? - ipsilateral retrograde access what intervention (if any) was required? - additional procedure scheduled for (b)(6) 2026 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G., kink)? - no was there evidence of post deployment stent compress or deformation? - crushed/deformed into itself, due to the pushing.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? - yes 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
• MDR Report Key: 25232294
• Report Number: 3005580113-2026-00028
• Device Sequence Number: 10183529
• Product Code: NIO
• UDI-Device Identifier: 10827002182827
• UDI-Public: (01)10827002182827(17)281201(10)C2372574
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2026
• Report Date (Section F): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G18282
• Device Catalogue Number: ZFV6-35-125-6-100
• Device Lot Number: C2372574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/20/2026