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

Catalog Number ZFV6-125-8-8.0

Device Problems Structural Problem (2506); Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

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

After balloon dilation, the physician pull out the red safety valve, but the stent did not released.Then the physician replaced another new device to completed this procedure successfully.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.Patient/event info notes: what was the target location for the complaint device? iliac artery.Was the device used percutaneously? yes.Which artery was the stent to be placed in? iliac artery was the approach ipsilateral or contralateral? contralateral.If contralateral, was the bifurcation angle tight? no.Where on the patient was the percutaneous access site? right femoral artery.Details of access sheath used (name, fr size, length)? kcfw-6.0-38-55-rb-raabe.Was the device flushed through both flushing port before the procedure, as per ifu? yes.Details of the wire guide used (name, diameter, hyrdophyllic)? hwas-35-260.Was the patient's anatomy tortuous or calcified? slight tortuous.Was resistance encountered when advancing the wire guide or delivery system to the target location?no.Was pre-dilation performed ahead of placement of the stent? yes.Was post-dilation performed after the placement of the stent? the stent has not deployed.Did the tip of the delivery system cross the target location? yes.Are images of the device of procedure available? no.Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? yes.

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 report being submitted due to device being evaluated in the lab at cirl on (b)(6) 2020.After balloon dilation, the physician pull out the red safety valve, but the stent did not released.Then the physician replaced another new device to completed this procedure successfully.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.Patient/event info - notes: 1.What was the target location for the complaint device? iliac artery.2.Was the device used percutaneously? yes.3.Which artery was the stent to be placed in? iliac artery.4.Was the approach ipsilateral or contralateral?.Contralateral.5.If contralateral, was the bifurcation angle tight? no.6.Where on the patient was the percutaneous access site? right femoral artery.7.Details of access sheath used (name, fr size, length)? kcfw-6.0-38-55-rb-raabe.8.Was the device flushed through both flushing port before the procedure, as per ifu? yes.9.Details of the wire guide used (name, diameter, hyrdophyllic)? hwas-35-260.10.Was the patient's anatomy tortuous or calcified? slight tortuous.11.Was resistance encountered when advancing the wire guide or delivery system to the target location?no.12.Was pre-dilation performed ahead of placement of the stent? yes.13.Was post-dilation performed after the placement of the stent? the stent has not deployed.14.Did the tip of the delivery system cross the target location?.Yes.15.Are images of the device of procedure available? no.16.Did the user pull the handle toward the hub during deployment and delivery system was not pushed during deployment? yes.

Manufacturer Narrative

Supplemental cancellation report being submitted due to the investigation being completed on 09-feb-2021 and a low risk failure mode being assigned.Fda mdr reporting criteria not met due to no serious injury being reported, no device malfunction precedence and overall risk of low indicates no potential for serious injury to occur.Device evaluation: the zfv6-125-8-8.0 device of lot number c1724043 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 06 november 2020.On evaluation of the device it was observed that the outer sheath had separated from the handle (i.E.Pulled through the white connector cap) at the distal end of the handle.The device flushed with no issues and 0.035 wire guide passed through the device as expected.The red safety lock was not returned.The stent was still contained in the outer sheath of the device.The stent could not be deployed in lab due to handle separation.Document review: prior to distribution zfv6-125-8-8.0 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 zfv6-125-8-8.0 of lot number c1724043 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 c1724043.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 difficult patient anatomy.It is possible that a difficult patient anatomy caused or contributed to resistance during deployment which increased the deployment force along the outer sheath.It is likely that the increased force during deployment resulted in the outer sheath separating from the handle during deployment leading to the inability for the user to deploy the stent.Summary: complaint is confirmed as the failure was verified in the laboratory and the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental cancellation report being submitted due to the investigation being completed on 09-feb-2021 and a low risk failure mode being assigned.Fda mdr reporting criteria not met due to no serious injury being reported, no device malfunction precedence and overall risk of low indicates no potential for serious injury to occur.

• 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: 10837675
• MDR Text Key: 250584612
• Report Number: 3001845648-2020-00866
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002518879
• UDI-Public: (01)10827002518879(17)230410(10)C1724043
• 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: 02/09/2021

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: 04/10/2023
• Device Catalogue Number: ZFV6-125-8-8.0
• Device Lot Number: C1724043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 10/16/2020
• Supplement Dates FDA Received: 12/04/2020; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65