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

Catalog Number ZIV6-125-6-4.0

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Abdominal aortic angiography was performed by femoral vein puncture, and the abdominal trunk vessels were narrowed.Kcfw-6.0-35-55-rb-hfanl1-hc, hnb5.0-38-80-p-ns-c2, and boston scientific 18 wire guide were used to reach the abdominal trunk vessels, and then the balloon was dilated by barty medical.Prepare to implant the stent ziv6-125-6-4.0 but the stent cannot enter the sheath.And the doctor tested sheath with medtronic 6f guided catheter.It was found that the guided catheter could pass normally, so the doctor believed that there was a quality problem with the vascular stent.After the angiography, there was partial blood flow in the trunk vessels of the abdominal cavity, the hepatic artery, the splenic artery, and the superior mesenteric artery.The procedure was completed, because no spare stent of the same rpn was prepared and other stent of different specifications were not suitable for this procedure, no stent was implanted in this procedure.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

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.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18667394
• MDR Text Key: 336298331
• Report Number: 3001845648-2024-00047
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-125-6-4.0
• Device Lot Number: C2060419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/06/2023
• Event Location: Hospital
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial