MAUDE Adverse Event Report: COOK MEDICAL IRELAND ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number	G43868
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per the district manager: i received a call today from this account about a stent that fractured.I am still gathering the information about the occurrence.The following information was received via email on 25mar2025."the patient was 68 y/o female with pancreatic adenocarcinoma.She was 5¿2¿ and 110 lbs.Patient had placement of internal/external biliary drainage.On (b)(6)2025 the stent was internalized with a zilver stent gpn-g43868, lot # c2138632.An internal/external biliary drain was left through the zilver stent.Patient was brought back on (b)(6)2025 for injection and removal of biliary drain.The stent appeared to be intact then.Patient returned to endoscopy (b)(6)2025 for repeat scope.It was noted then that the stent was fractured.Patient returned to ir for percutaneous biliary drainage on (b)(6)2025.Doctor was unable to gain access inn the biliary tree as the patients¿ ducts were not dilated.Internal stent was draining and not occluded.There was no adverse effects at this time as the stent was still draining ducts." a formal complaint was not filed or reported.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK MEDICAL IRELAND; o'halloran rd; national technology park; limerick
• MDR Report Key: 21741297
• Report Number: 3005580113-2025-00022
• Device Sequence Number: 9001729
• Product Code: NIO
• UDI-Device Identifier: 10827002438689
• UDI-Public: (01)10827002438689(17)270202(10)C2138632
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2025
• Report Date (Section F): 04/01/2025

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
• Device Model Number: G43868
• Device Catalogue Number: ZIV6-35-80-10-80
• Device Lot Number: C2138632
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/07/2025
• Device Age: 397
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Date Report Sent to FDA: 04/01/2025