MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number G43771

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

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: p050017/s002 and s003.

Event Description

I had a case today that the 518 stent 6x40 was already flowering after removing it from the package.It never entered the sheath or the patient.The problem was visualized prior to use and thus caused no harm.Patient outcome: n/a not used.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: p050017/s002 and s003.

Event Description

Supplemental report being submitted due to completion of the lab evaluation on 28-jul-21 - "stent partially deployed".

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Device evaluation: the ziv5-18-125-6-40 device of lot number c1781789 involved in this complaint was returned for evaluation, without its original packaging.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 28th july 2021.On evaluation of the device it was observed that approx.0.4 cm of the stent was partially deployed at the distal end of outer sheath at distal white tip.Document review: prior to distribution ziv5-18-125-6-40 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 ziv5-18-125-6-40 of lot number c1781789 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 c1781789.It should be noted that the instructions for use are ifu0043-9.There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause of damage during transport or storage of the device is assigned to this complaint.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 device did not make patient contact as the defect was spotted by the physician before use.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12156824
• MDR Text Key: 261296308
• Report Number: 3001845648-2021-00550
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002437712
• UDI-Public: (01)10827002437712(17)231202(10)C1781789
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2021

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 Expiration Date: 12/02/2023
• Device Model Number: G43771
• Device Catalogue Number: ZIV5-18-125-6-40
• Device Lot Number: C1781789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 06/18/2021; 06/18/2021
• Supplement Dates FDA Received: 08/25/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1