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

Catalog Number ZFV6-125-8-6.0

Device Problems Premature Activation (1484); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

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

The user opened the packaging and check the device found that part of the stent deployed, then the user replaced another new stent t with same type to completed this procedure successfully.Patient outcome: this occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Annex g: g04122 - stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to lab evaluation being completed on 12-feb-2021.The user opened the packaging and check the device found that part of the stent deployed, then the user replaced another new stent t with same type to completed this procedure successfully.Patient outcome: this occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Device evaluation the zfv6-125-8-6.0 device of lot number c1716164 involved in this complaint was returned for evaluation, without the 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 12th of feb, 2021.Refer to attachments pr 318801_lab attendance and pr 318801_lab evaluation notes for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos (ref att.'pr 318801_lab_decon evaluation photos').On evaluation of the device, partial stent deployment was observed on the distal end of the outer sheath.The device flushed as expected.A 0.35¿ wire guide passed through the device without issues.Approx.2cm of stent partially deployed on return.The red safety lock was not returned.Blood was observed on the distal tip and some blood was observed during device flushing.Document review: prior to distribution zfv6-125-8-6.0 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 zfv6-125-8-6.0 of lot number c1716164 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 c1716164.There is no evidence to suggest the user did not follow the instructions for use (ifu0058-4).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 could be attributed to the absence of the red safety tab.As it was not present on the device while opening.It is possible that the red safety tab may have become dislodged as a result of impact during transportation.Absence of the red safety tab could have caused the sent to be partially deployed during transportation.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 patient did not require any additional procedures as a result of the occurrence.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 FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11331293
• MDR Text Key: 232741556
• Report Number: 3001845648-2021-00107
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002518909
• UDI-Public: (01)10827002518909(17)230316(10)C1716164
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZFV6-125-8-6.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Event Location: Hospital
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 59