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

Model Number	G43868
Medical Device Problem Codes	Premature Activation (1484); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When the physician started to insert the delivery system along the gw outside the patient's body, the stent became exposed (expanded) even though the safety lock was engaged.He completed the procedure with another manufacturer's deice (detail unknown).
Event or Problem Description
Supplemental report is being submitted as a cancellation report following the receipt of additional information on 16 may 2025 that the description of the event was incorrect and the complaint no longer meets the description of a reportable incident.Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.The original report incorrectly indicated that the stent became exposed during insertion outside the patient¿s body, despite the safety lock being engaged.As a result, the physician used a device from a different manufacturer to complete the procedure (specific details of the alternate device are unavailable).The correct event involved treatment of the right iliac artery accessed via the left femoral artery.A ziv6-35-80-10-80 stent was inserted, but deployment at the target lesion was unsuccessful.After removing the safety tab, the physician attempted deployment again at the stenosis site, but it remained unsuccessful.The stent was then removed from the patient¿s body, and an attempt to deploy it outside the body resulted in partial deployment, which required significant force.
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Supplemental report is being submitted as a cancellation report following the receipt of additional information on 16 may 2025 that the description of the event was incorrect and the complaint no longer meets the description of a reportable incident.Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.The original report incorrectly indicated that the stent became exposed during insertion outside the patient¿s body, despite the safety lock being engaged.As a result, the physician used a device from a different manufacturer to complete the procedure (specific details of the alternate device are unavailable).The correct event involved treatment of the right iliac artery accessed via the left femoral artery.A ziv6-35-80-10-80 stent was inserted, but deployment at the target lesion was unsuccessful.After removing the safety tab, the physician attempted deployment again at the stenosis site, but it remained unsuccessful.The stent was then removed from the patient¿s body, and an attempt to deploy it outside the body resulted in partial deployment, which required significant force.

• 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
• Manufacturer (Section G): COOK MEDICAL IRELAND; o'halloran rd; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick ; 061334440
• MDR Report Key: 21812537
• Report Number: 3001845648-2025-00179
• Device Sequence Number: 18351630
• Product Code: NIO
• UDI-Device Identifier: 10827002438689
• UDI-Public: (01)10827002438689(17)260814(10)C2080479
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 06/12/2025

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: 08/14/2026
• Device Model Number: G43868
• Device Catalogue Number: ZIV6-35-80-10-80
• Device Lot Number: C2080479
• 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: 03/14/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2023
• 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