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

Catalog Number ZFV6-80-9-4.0

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

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

Event Date 05/20/2022

Event Type  malfunction  

Event Description

Product released automatically when opened the package."as per cc form": when the doctor opened the package, he noticed that the stent was loose in the package.No one had touched the release system and the red locking pin was also normally in the system.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.No contact with patient.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p050017/s006 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental mdr being submitted due to lab evaluation completed on 20-june-2022 lab evaluation 20th june : visual inspection red safety tab returned in place stent returned separately intact.Functional inspection 0.035'' wire guide passed through device with no issue.Device flushed as intended.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Device evaluation the zfv6-80-9-4.0 device of lot number c1899061 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6)2022.Refer to attachments ¿zilver lab evaluations attendance (b)(6) 2022¿ for lab attendance.On evaluation of the device, it was found that the red safety tab was returned in place.The stent was returned separately intact.No other defects were found.The device flushes as intended and a 0.035¿ wire guide passed through the device with no issue.Document review prior to distribution zfv6-80-9-4.0 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zfv6-80-9-4.0 of lot number c1899061 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1899061.There is no evidence to suggest the user did not follow the instructions for use, ifu0058.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to damage to the device caused by impact during shipping.It is possible that the device was subjected to impact during transportation in its original packaging, which may have caused components in the handle of the device to become damaged/cracked, which may have led to or contributed to the deployment of the stent.Summary complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The damaged device was not used in any procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental mdr being submitted due to completed investigation on 05-aug-2022.

• Brand Name: ZILVER FLEX 35 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: 14712495
• MDR Text Key: 294574206
• Report Number: 3001845648-2022-00361
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002519173
• UDI-Public: (01)10827002519173(17)250104(10)C1899061
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: ZFV6-80-9-4.0
• Device Lot Number: C1899061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/20/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 05/20/2022; 05/20/2022
• Supplement Dates FDA Received: 07/18/2022; 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1