MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-8.0-40-PTX

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

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

Event Date 07/14/2023

Event Type  malfunction  

Event Description

This was an shallow femoral artery treatment with an ipsilateral approach.When the stent was deployed, it jumped and didn't cover the lesion.An additional another zisv6-35-125-8.0-40-ptx (lot#:unknown) was used to complete the procedure.No adverse effect on the patient has been reported.Physician's comment: i think it was normal usage.4.Prefix ziv6-ptx/zisv6-ptx: 4-1.Are images of the device of procedure available? no image available.4-2.Was the approach ipsilateral or contralateral? (ipsilateral).4-3.If contralateral, was the bifurcation angle tight? unknown.4-4.Was pre-dilation performed ahead of placement of the stent? yes.4-5.Was post-dilation performed after the placement of the stent? yes.4-6.Details of the wire guide used (name, diameter, hyrdophyllic)? terumo/radifocus 0.035inch 220cm.4-7.Details of access sheath used (name, fr size, length)? terumo/6fr 10cm.4-8.Was the device flushed before the procedure, as per ifu yes.4-9.What was the target location for the stent? sfa.4-10.Was the patient's anatomy tortuous or calcified? neither.4-11.Was resistance encountered when advancing the wire guide or delivery system to the target location? no.4-12.How did the physician deal with this resistance? 4-13.Did the stent delivery system cross the target location? yes.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Device evaluation: the zisv6-35-125-8.0-40-ptx zilver ptx device of lot number c2001288 involved in this complaint was not available for evaluation.The device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review prior to distribution all zisv6 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.Review historical data; the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/or label: the japanese packaging insert c-ci1502m06 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.This states the following: ¿note: the distal end of the stability sheath should be inside the access sheath.¿ there is evidence to suggest the user did not follow the japanese packaging insert.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause was determined from the available information.It is known from the information provided that the distal end of the stability sheath was not inside the access sheath.This could have caused the stent to jump on deployment.Not inserting the distal end of the stability sheath into the access sheath results in the delivery system not being adequately held in place during deployment which can lead to the stent ¿jumping¿ or being suddenly released from the delivery system.The user has not complied with the requirements of the japanese packaging insert with respect to the intended use of the device.User/use error complaints are considered foreseen misuse.It should be noted that, as the device was used outside of their validated state and/or against the instructions provided in the japanese packaging insert, it is not possible to predict how the devices will perform or function.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the initial reporter, this was an shallow femoral artery treatment with an ipsilateral approach.When the stent was deployed, it jumped and didn't cover the lesion.An additional another zisv6-35-125-8.0-40-ptx (lot#:unknown) was used to complete the procedure.Confirmed quantity of (b)(4) device, confirmed used.According to the paper, the patients did not suffer any adverse effects due to this occurrence.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the japanese packaging insert in regards to the correct wire guide to be used with the device.As previously noted, the packaging insert states that the distal end of the stability sheath should be inside the access sheath.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 on 21-feb-2024.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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
• MDR Report Key: 17508225
• MDR Text Key: 321723547
• Report Number: 3001845648-2023-00624
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-8.0-40-PTX
• Device Lot Number: C2001288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2023
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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