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

Catalog Number ZFV6-80-9-6.0

Device Problems Premature Activation (1484); Activation Failure (3270)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Device evaluation: the zfv6-80-9-6.0 device of lot number c1752078 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 23 april 2021.Refer to attachment¿s pr (b)(4), lab attendance and pr (b)(4) lab evaluation notes for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device it was noted that the stent was partially deployed at approximately 2.0mm at the distal end of the outer sheath at the distal white tip.The device flushed as expected and some blood was observed in the distal white tip.A 0.035¿ wireguide passes as expected.The information provided by the customer indicated that the product was partially deployed when the device was opened prior to use and it made no patient contact.Following the observation of the blood during the lab evaluation an additional request for information was made to the customer about confirming that the device had not made patient contact.Also, an explanation as to how the blood got into the distal tip was requested.At the time of the investigation this information has not been received.If this information is received at a later date the file will be updated.Document review: prior to zfv6-80-9-6.0 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 (b)(4).A review of the manufacturing records for zfv6-80-9-6.0 of lot number c1752078 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 c1752078.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.The customer confirmed that the packaging was observed before use and not found to be damaged.A possible root cause could be attributed to how the device was handled when being removed from the packaging.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter the device did not make contact with the patient.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.

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

Product partially deployed when device opened prior to use! 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.

Event Description

Supplemental follow-up report is being submitted due to the receipt and evaluation of the complaint device.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Device was evaluated on 23-apr-2021.Approximately 2mm of the stent was noted to be partially deployed.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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: 11335537
• MDR Text Key: 270361227
• Report Number: 3001845648-2021-00110
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002519197
• UDI-Public: (01)10827002519197(17)230819(10)C1752078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

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 Expiration Date: 08/19/2023
• Device Catalogue Number: ZFV6-80-9-6.0
• Device Lot Number: C1752078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/14/2021
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1