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

Model Number G38482

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.

Event Description

During deployment of the stent, the triaxle system broke about 1/4 of the way during deployment.The user broke open the handle and pulled back toward the red tab to deploy the stent.The stent was deploying very slowly and took force.The product manager was contacted and the user pulled back on the system to try to deploy the stent; at this time, the stent broke/separated.The deployment system, wire, and portion of the stent were removed together from the patient.A section of the stent remains in the patient and was ballooned and left in the patient.During a run, it was determined the stent was open.As the aortic bifurcation is very steep and tortuous, iliac stents are present in both iliacs and calcification in the common femoral artery, the physician did not go back in as there is potential of the event occurring again.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) #p100022/s014.This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.The zisv6-35-125-6-120-ptx device of lot number c1386417 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.From customer testimony, it is known that the device was advanced over a 0.014¿ diameter, choice extra support wire guide.The device was flushed prior to use.A portion of the stent remained in the patient.The aortic bifurcation was very steep and tortuous, and there was calcification in the common femoral artery.Pre-dilation was conducted prior to stent deployment.The customer has confirmed that images of the procedure are not available at this time.On evaluation of the returned device, significant rippling damage was observed on the distal stent retraction sheath (srs), and the stent retraction sheath was shape set.The retraction wire was found to be separated from the stent retraction sheath.The device was returned with a 0.013¿ diameter wire guide still loaded in the device lumen.The device was returned with a portion of the stent still loaded in the stent retraction sheath, and there was evidence that the stent was fractured.The evaluating engineers determined that 8.5cm of the stent was still loaded into the stent retraction sheath.Complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated from the stent retraction sheath.Possible causes for this occurrence could include the use of a non-recommended wire guide, or the difficult patient anatomy.It is known that the complaint device was advanced and deployed with a 0.014¿ diameter wire guide.The wire guide could have provided insufficient support during deployment.The customer also reported that the patient¿s aortic bifurcation was very steep and tortuous, and the patient had a calcified common femoral artery.The patient anatomy could have created resistance during deployment.These factors could have caused or contributed to the damage to the sheath and the retraction wire separating from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that as per the product instruction for use: precautions: ¿a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system¿ prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1386417.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The broken stent portion was affixed to the vessel wall by balloon dilation.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial report details: during deployment of the stent, the triaxle system broke about 1/4 of the way during deployment.The user broke open the handle and pulled back toward the red tab to deploy the stent.The stent was deploying very slowly and took force.The product manager was contacted and the user pulled back on the system to try to deploy the stent; at this time, the stent broke/separated.The deployment system, wire, and portion of the stent were removed together from the patient.A section of the stent remains in the patient and was ballooned and left in the patient.During a run, it was determined the stent was open.As the aortic bifurcation is very steep and tortuous, iliac stents are present in both iliacs and calcification in the common femoral artery, the physician did not go back in as there is potential of the event occurring again.

• 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 Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7116435
• MDR Text Key: 95790500
• Report Number: 3001845648-2017-00591
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)180616(10)C1386417
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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