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

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

Device Problem Occlusion Within Device (1423)

Patient Problems Stenosis (2263); Claudication (2550)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022 and s001.Ziv6-35-125-6-80-ptx stent of lot number c937506 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation will be carried out.Images are available and are with cook research inc.(cri) for review.Upon receipt of imaging review the investigation will be updated and an assessment will be completed to determine if a follow-up mdr report will be required to be submitted.Available information stated that the patient had pre-existing conditions including coronary artery disease, hypertension, diabetes mellitus type ii, hypercholesterolemia and was a current smoker.Patient enrolled in study to treat the right distal superficial femoral artery.There was moderate calcification and no thrombus or previous intervention in the study lesion.The percent diameter stenosis in the study lesion was 80%.According to complaint information worsened claudication was observed in the patient prior to a stent placement in the right iliac artery.It can be noted that worsen claudication indicates progression of peripheral artery disease and can also be associated with the restenosis process.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 surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however a definitive cause of this event cannot be determined.According to information provided the treating physician cited peripheral arterial disease as a pre-existing condition that caused or contributed to the event.However a definite cause of the occurrence cannot be determined.As no imaging was available at the time of complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that worsened claudication and restenosis of the stented artery are known potential adverse events associated with placement of this device.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.According to information provided atherectomy and balloon angioplasty were performed and no adverse events were experienced by the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Protocol 12-004, patient (b)(6), right distal superficial femoral artery: on (b)(6) 2013, the patient underwent orbital atherectomy of the study lesion before two 6 mm x 80 mm zilver® ptx® v study stents (ziv6-35-125-6-80-ptx of lot# c937506/lot# c936024) were placed via contralateral access.Pre-stent dilatation was not performed.The implanting physician noted that ease of device deployment was very easy.No non-study stents were used to treat the study lesion.Post-stent dilatation was performed with two inflations of a 5.0 mm x 60 mm balloon at 8 atm for 30 seconds and one inflation at 10 atm for 30 seconds.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was apposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.The proximal and distal rvds were 6.0 mm.The post-procedural abis were not performed.Core lab analysis of the final lesion morphology revealed a proximal rvd of 4.26 mm, a distal rvd of 4.37 mm, an mld of 3.09 mm, and 27.46% residual stenosis.There was no thrombus, perforation, distal embolization, or dissection noted by the core lab.On (b)(6) 2014 (157 days post-procedure), the patient had a stent placed in the right iliac artery (intra-arterial location unknown) due to worsened claudication/rest pain.The twelve month follow-up clinical assessment, x-ray, and ultrasound were not performed.On (b)(6) 2015 (665 days post-procedure), the two year follow-up clinical assessment and ultrasound were completed.The right and left abis were 0.72 and 0.95 respectively.The right rutherford classification was three and the left leg was one.The ultrasound revealed the stent was patent proximal and distal to the study lesion, but 50-99% stenosed within.Core lab analysis of the two-year follow-up ultrasound is not available.On (b)(6) 2015 (686 days post procedure), the patient underwent a secondary intervention to the study lesion due to an occlusion/restenosis and persistent claudication.Treatment included atherectomy and balloon angioplasty.The treating physician stated that the event was probably related to the study product [site queried] and study procedure, and cited peripheral arterial disease as a pre-existing condition that caused or contributed to the event.As per the above description of event received, two devices are involved in this incident.This report addresses the investigation of 1 x ziv6-35-125-6-80-ptx of lot# c937506.An additional report will be submitted in relation to the other device reported- report reference numbers:3001845648-2015-00236.

Manufacturer Narrative

(b)(4) ziv6-35-125-6-80-ptx stent of lot number c937506 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation will be carried out.From information provided it is known that the patient had pre-existing conditions including coronary artery disease, hypertension, diabetes mellitus type ii, smoking (current), and hypercholesterolemia.The patient enrolled in study to treat the right distal superficial femoral artery.In addition worsened claudication was observed in the patient prior to stent placement in the right iliac artery.It can be noted that worsen claudication indicates progression of peripheral artery disease and can also be associated with the restenosis process images were provided and were independently reviewed with the following comments: ¿findings: the distal most stent extended completely across the lesion.The proximal stent was not placed in a specific stenosis or dissection; rather it was implanted in a 7cm long 4mm diameter segment.Three vessel runoff without popliteal or calf artery stenosis was imaged to mid-calf.Its rapidity supported normal distal runoff.Follow up ultrasound demonstrated a focal centimeter long mound shaped stenosis in the proximal stent¿¿no other stenosis was imaged from the cfa to the ankle.The decreased right abi correlated with the ultrasound findings.Impression: the complaint lesion was a focal 50-99% proximal zilver ptx in-stent stenosis.The stenosis was consistent with neointimal hyperplasia.This stent was implanted in a sfa segment that originally lacked a discrete lesion.Risk factors for neointimal hyperplasia included continued tobacco abuse and a 30% inflow stenosis.Additionally the severe profunda femoral artery and cfa atherosclerosis were evidence of aggressive atherosclerotic disease.¿ according to the independent reviewer the proximal zilver ptx in-stent stenosis was consistent with neointimal hyperplasia.Therefore, the customer complaint can be confirmed as imaging revealed restenosis.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 the drug paclitaxel to help prevent subsequent restenosis of the artery.According to the opinion of the independent reviewer, the stenosis was consistent with neointimal hyperplasia.Patient risk factors for neointimal hyperplasia included continued tobacco abuse and a 30% inflow stenosis.Additionally the severe profunda femoral artery and cfa atherosclerosis were evidence of aggressive atherosclerotic disease.Based on the above, it can be stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction.However as the conditions of use cannot be replicated a definitive root cause cannot be determined.It may be noted that as per instructions for use restenosis of the stented artery is a known potential adverse event associated with placement of this device.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.According to information provided atherectomy and balloon angioplasty were performed.No other adverse events have been reported for this patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.Pma/510(k) # p100022 and s001.

Event Description

This follow up report is being submitted due to the receipt and review of images related to this event.Initial description submitted as follows: (b)(4) right distal superficial femoral artery: on (b)(6) 2013, the patient underwent orbital atherectomy of the study lesion before two 6 mm x 80 mm zilver ptx v study stents (ziv6-35-125-6-80-ptx of lot# c937506/lot# c936024) were placed via contralateral access.Pre-stent dilatation was not performed.The implanting physician noted that ease of device deployment was very easy.No non-study stents were used to treat the study lesion.Post-stent dilatation was performed with two inflations of a 5.0 mm x 60 mm balloon at 8 atm for 30 seconds and one inflation at 10 atm for 30 seconds.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was apposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.The proximal and distal rvds were 6.0 mm.The post-procedural abis were not performed.Core lab analysis of the final lesion morphology revealed a proximal rvd of 4.26 mm, a distal rvd of 4.37 mm, an mld of 3.09 mm, and 27.46% residual stenosis.There was no thrombus, perforation, distal embolization, or dissection noted by the core lab.On (b)(6) 2014 (157 days post-procedure), the patient had a stent placed in the right iliac artery (intra-arterial location unknown) due to worsened claudication/rest pain.The twelve month follow-up clinical assessment, x-ray, and ultrasound were not performed.On (b)(4) 2015 (665 days post-procedure), the two year follow-up clinical assessment and ultrasound were completed.The right and left abis were 0.72 and 0.95 respectively.The right (b)(4) classification was three and the left leg was one.The ultrasound revealed the stent was patent proximal and distal to the study lesion, but 50-99% stenosed within.Core lab analysis of the two-year follow-up ultrasound is not available.On (b)(6) 2015 (686 days post procedure), the patient underwent a secondary intervention to the study lesion due to an occlusion/restenosis and persistent claudication.Treatment included atherectomy and balloon angioplasty.The treating physician stated that the event was probably related to the study product [site queried] and study procedure, and cited peripheral arterial disease as a pre-existing condition that caused or contributed to the event.As per the above description of event received, two devices are involved in this incident.This report addresses the investigation of 1 x ziv6-35-125-6-80-ptx of lot# c937506.An additional report will be submitted in relation to the other device reported- report reference numbers:3001845648-2015-00236.

• 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: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5226003
• MDR Text Key: 31327282
• Report Number: 3001845648-2015-00236
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2015
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• 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 Age: 59 YR