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

Catalog Number ZFV6-80-7-4.0

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

Customer used the product this afternoon.Stent failed to deploy out of delivery sheath correctly and was stuck inside catheter.

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 follow-up is being submitted due to additional information received on 17-oct-2022 as follows: 1.Are images of the device or procedure available? no.2.At what stage of the procedure did the complaint occur? stent placement, 3.Details of access sheath used (name, fr size, length)? 6 fr likely.4.What was the target location for the stent? eia.5.Was the product inspected for kinks or damage before use? yes, 6.Was the device used percutaneously? no.7.Was the device flushed through both flushing port before the procedure, as per ifu? yes.8.Was pre-dilation performed ahead of placement of the stent? yes.9.Was post-dilation performed after the placement of the stent? no.10.Details of the wire guide used (name, diameter, hydrophilic)? hydrophilic and then standard 0.035 ¿wire.11.Did the patient exhibit difficult or altered anatomy (if altered please specify how it is altered)? mild, tortuous, 12.Was resistance encountered when advancing the wire guide to the target location? no.13.Was resistance encountered when advancing the delivery system to the target location? no.14.How did the physician deal with this resistance? na.15.Was the approach ipsilateral or contralateral? ipsilateral.16.If contralateral, was the bifurcation angle steep? n/a.17.Did the tip of the delivery system cross the target location? yes.18.Was the delivery system tracked around a tight angle in the patient anatomy? no.19.Was the delivery system damaged/kinked/twisted during deployment? no.20.Was the handle pulled towards the hub during deployment? no.21.Was the delivery system pushed during deployment? stent system moved.22.Was the stent deployed smoothly / without resistance? no.23.If no, please detail any difficulty experienced during deployment: __movement of the stent delivery system and it was removed.24.What artery was the stent placed in? eia.25.Was the stent fully deployed from the delivery system prior to removal of the delivery system? no.26.Did the patient have any pre-existing conditions? no.27.If yes, please specify; 28.Did the patient require any additional procedures as a result of this event? different stent.29.What intervention (if any) was required? removed in its entirety.30.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? different stent deployed at the same time.31.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G., kink)? no.

Event Description

Supplemental cancellation report is being submitted due to the completion of the investigation on 17-feb-23.The event has been re-assessed and no longer meets the criteria of a ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Overall risk assessed as category low.No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Device evaluation: the zfv6-80-7-4.0 device of lot number c1721943 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity a review of the manufacturing records 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 for this work order.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0058).Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined from the available information.Possible root causes could be attributed to the patient anatomy that may have caused resistance to be encountered when attempting to deploy.The user has said that the patients anatomy was tortuous.This could have caused resistance when attempting to deploy the stent and in turn, caused the stent to get stuck inside the catheter.However, since the device was not returned for evaluation, we cannot definitively say what could have caused the stent to fail to deploy and get stuck inside the catheter.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Another device was used to complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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 ; 061334440
• MDR Report Key: 15377772
• MDR Text Key: 306336175
• Report Number: 3001845648-2022-00616
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002518886
• UDI-Public: (01)10827002518886(17)230401(10)C1721943
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: ZFV6-80-7-4.0
• Device Lot Number: C1721943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2022
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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