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

Catalog Number ZISV6-35-125-8-40-PTX

Device Problems Off-Label Use (1494); Structural Problem (2506); Deformation Due to Compressive Stress (2889)

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

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported by the dm on behalf of the customer via phone call - the physician stated the stent shortened upon deployment.It was supposed to be a 40 mm length and it ended up not being that length.Another stent was placed over the zilver ptx stent to cover the artery that was not covered by the shortening of the stent.

Event Description

This follow-up supplement report is being submitted due to the receipt of additional information on 23-nov-2020: additional information: after the manufacturer¿s review of the provided imaging they have requested the below information for (b)(4).1.Can you confirm if the approach was ipsilateral or contralateral? contralateral.2.Can you confirm if the additional stent placed after the complaint stent shortened was another ptx stent? no, it was an everflex stent by medtronics.Initial report details: reported by the dm on behalf of the customer via phone call - the physician stated the stent shortened upon deployment.It was supposed to be a 40 mm length and it ended up not being that length.Another stent was placed over the zilver ptx stent to cover the artery that was not covered by the shortening of the stent.

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) # (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This follow-up supplement report is being submitted due to the receipt and review of images relating to this event.The investigation into this event is still being carried out.A follow up report will be submitted with the investigation conclusions.

Manufacturer Narrative

Device evaluation the zisv6-35-125-8-40-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.Document review as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6-35-125-8-40-ptxdevices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0118-6) states the following : ensure the distal end of the stability sheath is inside the access sheath.The ifu does not contain instructions on the placement of the ptx stent within competitor stents.There is 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 1.A shorter implanted length compared to the labelled length of the zisv6-35-125- 8-40-ptx is confirmed.Initial deployment was in the constrained lumen of a supera stent.Deployment in a constrained lumen relative to the stent design diameter has been observed in other instances of a concertinaed deployment.This is analogous to implantation in a significant stenosis without or with only modest pre-implantation angioplasty.2.Although the complaint report states that access was contralateral, the imaging suggests that it may have been ipsilateral.If so, the stability sheath was possibly outside the access sheath.This could allow the delivery system to advance during deployment.Root cause review a definitive root cause of off-label use was identified from the available information.Deployment of a ptx stent within a non ptx stent such as a supera stent is considered off label usage.Summary complaint is confirmed as the failure was verified in the image.A shorter implanted length compared to the labelled length of the zisv6-35-125- 8-40-ptx is confirmed.It is possible that overlapping with a non ptx stent caused issues during deployment.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 report being submitted due to the investigation being concluded on 30-apr-2021.

• 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
• MDR Report Key: 10793017
• MDR Text Key: 233841127
• Report Number: 3001845648-2020-00834
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-8-40-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1