MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-7-80-PTX

Device Problems Dent in Material (2526); Material Deformation (2976)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Per dm email: issues with ptx on tuesday because it folded.He let me know about the issue with the device.I checked the images and noticed the issue.It looks like the stress or tangled together and didn¿t correct when he was deploying.He didn¿t cause an issue as he post dilated to stent.The issue was that it didn¿t look how it should.Did any unintended section of the device remain inside the patient¿s body? no was the patient hospitalized or was there prolonged hospitalization? no did the patient require any additional procedures due to this occurrence? no did the product cause or contribute to the need for additional procedures? no has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effects? n/a the following information has been received via email on 19oct2022.(b)(6) 2022 how was the procedure able to be completed? the stent was posted dilated as he normally does.The following information has been received via email on 14oct2022.(b)(6) 2022 are images (e.G.Angiography, us etc.) of the device and/or procedure available? yes, provided in the original email.The following information has been requested via email on 19oct2022.Sg 19oct2022 was the device flushed before the procedure, as per ifu? were there any issues with flushing of the device? details of the access sheath used (name, fr size, length)? details of the wire guide used (name, diameter, hyrdophyllic)? what approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other please specify for other: if contralateral, was the bifurcation angle steep? what was the target location for the stent? what artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other please specify for other: was the wire guide removed from the patient prior to advancing the delivery system? if removed, was the wire guide wiped prior to advancement of the delivery system? did the stent delivery system cross the target location? was pre-dilation performed ahead of placement of the stent? was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other if other, please specify: was resistance encountered when advancing the wire guide? was resistance encountered when advancing the delivery system to the target location? was resistance encountered when deploying the stent? how did the physician deal with any resistance encountered? was the stent fully deployed in the patient before removing the delivery system? after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other if other, please specify: was post-dilation performed after the placement of the stent? did any portion of the device break off? if yes, please state what part: when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? thumbwheel only ¿ was the retraction sheet being held during deployment.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? a.If yes, was the stent partially deployed? if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed if removed, did any part of the stent fracture during removal of the delivery system? was the delivery system kinked or twisted during advancement or deployment? please advise if and when any damage was observed on the; wireguide -prior to use, during use, post procedure delivery system -prior to use, during use, post procedure if yes, please specify (e.G.Kinked or twisted): what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? please specify if yes.

Event Description

Supplemental report is being submitted due to lab evaluation (image review) completed on (b)(6) 2022.

Manufacturer Narrative

Pma/510(k) # p100022/s014 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p100022/s014 investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the receipt of clinical input on (b)(6)2022.Clinical input received as follows : as per the imaging review, the root cause more than likely the physician possibly attempted to reposition the stent.

Manufacturer Narrative

Device evaluation the zisv6-35-125-7-80-ptx device of unknown lot number involved in this complaint was implanted in the patient and 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 manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use (ifu0118) states the following: ¿once the stent has opposed the vessel wall repositioning of the stent is not recommended¿.There is no evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression the complaint of abnormal stent deployment is confirmed.The mid stent was concertinaed.The circumstances were more complex than stent implantation within a previously untreated sfa occlusion.A stent consistent with a zilver stent was present in the distal sfa.An over stretched stent was likely in between the distal stent and the complaint stent.Interference and/or attempted repositioning resulting in the complaint cannot excluded.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the delivery system being moved during deployment.If the delivery system was moved during deployment it is possible that the struts of the stent became caught on one another during deployment resulting in the proximal end of the stent remaining closed or tanged on deployment.Another possible root cause could be attributed to user technique whereby the physician attempted to adjust/reposition the stent after deployment.As per the imaging review ¿interference and/or attempted repositioning resulting in the complaint cannot excluded¿.It is also possible that a difficult patient anatomy may have compressed the stent upon deployment, preventing the stent from expanding fully at the same rate.However, no device was returned for evaluation for this complaint a definitive root cause cannot be determined.Summary complaint is confirmed as the failure was verified in the image(s).As per image review, the complaint of abnormal stent deployment is confirmed.The mid stent was concertinaed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The user post dilated the stent.The issue was that it didn¿t look how it should.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This supplemental report is being submitted due to completion of the investigation on the 16-may-2023.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING 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: 15779066
• MDR Text Key: 308021703
• Report Number: 3001845648-2022-00763
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2022
• Event Location: Hospital
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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