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

Catalog Number ZIV6-35-125-6-80-PTX

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Reocclusion (1985); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

On (b)(6) 2013, two zilver stents were placed in the left distal sfa (lot #'s c909543).On (b)(6) 2014, the patient had an ultrasound of the study lesion and it revealed patency proximal and distal to the study lesion, but a 50 99% stenosis within the study lesion.No intervention was performed.Sometime between (b)(6) 2015 (587 days post procedure) and (b)(6) 2015 (596 days post procedure), the patient had an occlusion/restenosis requiring intervention.Treatment included an arterectomy and ba!loon angioplasty.The site related the event to pre existing peripheral vascular disease.As per the above description of event received, two devices are involved in this incident.An additional separate report will be submitted in relation to the other device reported- report reference number 3001845648 2015 00105.

Manufacturer Narrative

(b)(4).The ziv6-35-125-6-80-ptx stent of lot number c909543 reported in this incident was implanted in the patient and therefore is not available for evaluation.With the information provided a document based investigation was carried out.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Images in relation to the reported incident were provided to support the complaint investigation.These images were reviewed and the following comments in relation to restenosis were provided by the independent reviewer: "findings:.Ultrasound was performed (b)(6) 2014.Although the provided imaging quality is limited, it demonstrated hemodynamically significant stenoses in the mid sfa and in the mid distal stented segment.The patient returned for fluoroscopy of the stented segment (b)(6)2014 concurrent with the ultrasound that reportedly documented severe in-stent stenosis.Re-repeat intervention six months later consisted of mechanical embolectomy with distal protection, angioplasty, and likely in-stent drug eluting balloon angioplasty.The fracture was not associated with thrombus or neointimal hyperplasia.Inflow was limited by progressive moderate left sfa origin and stable moderate mid sfa stenoses.The in-stent stenosis did not improve with embolectomy demonstrating that the stenosis was neointimal hyperplasia.Although neointimal hyperplasia extended through the entire stented segment except at the fracture, it was moderate in the proximal stent mid third and in the distal stent inferior half.In the mid distal stent, the stenosis was severe.The popliteal artery stenosis had improved except just superior the tibial peroneal trunk origin where it remained smaller than the tibial peroneal trunk.One vessel distal runoff via the peroneal artery was unchanged.Impression:.Neointimal hyperplasia caused moderate proximal and moderate and severe distal in-stent stenosis.This was relieved with angioplasty.Two moderate inflow stenoses and limited runoff increased the likelihood of in-stent stenosis.¿ based on the images provided, the customer complaint was confirmed as ultrasound and fluoroscopy revealed in-stent stenosis caused by neointimal hyperplasia.It can be noted that neointimal hyperplasia is the major cause of restenosis that occurs after interventions such as stenting or angioplasty.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with a drug (paclitaxel) to help prevent subsequent restenosis of the artery.Based on the opinion of the independent reviewer, two moderate inflow stenoses and limited runoff increased the likelihood of in-stent stenosis.Moreover, according to the reporting facility, pre-existing peripheral vascular disease was related to the event.It can be therefore stated that it is very unlikely that the restenosis could have occurred due to zilver ptx malfunction.According to instruction for use, restenosis of the stented artery is a known potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Post-intervention imaging confirmed that no significant stenosis through the stented segment remained and the moderate inflow stenosis were improved with angioplasty.No further adverse effects to the patient have been reported.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. regulatory aff ; 61334440
• MDR Report Key: 4780385
• MDR Text Key: 5799526
• Report Number: 3001845648-2015-00106
• 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
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C909543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR