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

Model Number G24890

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s014.The device evaluation for 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

Initial mdr required based on the requirement for a surgical intervention (intervention included balloon angioplasty, stent placement, and a femoral endarterectomy.) (b)(6): occlusion/restenosis of the study lesion, right sfa.On (b)(6) 2014, the patient received one zilver ptx study stent (6 mm x 80 mm) in the right distal sfa.On (b)(6) 2017, the patient reported worsening claudication of the right lower extremity.An ultrasound was performed and revealed stenosis within the study stent.On (b)(6) 2018, the patient had a cta of the right leg which revealed stenosis within the study stent.On (b)(6) 2018, the patient underwent re-intervention due to the occlusion/restenosis within the study lesion (right sfa).Symptoms included worsening claudication.The right rutherford classification was two.Pre-intervention angiography revealed 50-99% stenosis within the study lesion.Intervention included balloon angioplasty, stent placement, and a femoral endarterectomy.Core lab analysis of the angiography is not yet available.The event (occlusion/restenosis) was considered definitely related to the study product.Pre-existing peripheral vascular disease was also noted to have caused or contributed to the event.The site has not provided a response to the question (queried): did the device malfunction or deteriorate in characteristics or performance?.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4) (importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).(b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s014.Problem statement: "12-004 patient (b)(6): occlusion/restenosis of the study lesion, right sfa (superficial femoral artery).On (b)(6) 2014, the patient received one zilver ptx study stent (6 mm x 80 mm) in the right distal sfa.On (b)(6) 2017, the patient reported worsening claudication of the right lower extremity.An ultrasound was performed and revealed stenosis within the study stent.On (b)(6) 2018, the patient had a cta (computerised tomography angiography) of the right leg which revealed stenosis within the study stent.On (b)(6) 2018, the patient underwent re-intervention due to the occlusion/restenosis within the study lesion (right sfa).Symptoms included worsening claudication.The right rutherford classification was two.Pre-intervention angiography revealed 50-99% stenosis within the study lesion.Intervention included balloon angioplasty, stent placement, and a femoral endarterectomy.Core lab analysis of the angiography is not yet available.The event (occlusion/restenosis) was considered definitely related to the study product.Pre-existing peripheral vascular disease was also noted to have caused or contributed to the event.The site has not provided a response to the question (queried): did the device malfunction or deteriorate in characteristics or performance?" device evaluation: the ziv6-35-125-6-80-ptx device 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.From customer testimony, it is known that the patient had a previous history of coronary arterial disease, hypertension, hypercholesterolemia and is a current smoker.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.Is the complaint confirmed? yes.Seventy percent in-stent stenosis in the proximal ziv6-35-125-6-80-ptx developing between one and three years is confirmed.The late development and response to angioplasty were consistent with neointimal hyperplasia.The risk of neointimal hyperplasia was increased by progressive inflow limitation from severe progressive atherosclerotic stenosis of the right common femoral artery (cfa) and superficial femoral artery (sfa) origin.Observation of device effects, relative to the patient's anatomy: none.Observation of device effects, relative to the disease state: progressive atherosclerotic disease and neointimal hyperplasia were aggravated by the reported continued tobacco abuse.Observation of significant findings relative to the use of the device: none.Observation of additional device findings relative to the clinical perspective: none.Findings: 1.Angiography performed 10 days prior to implantation and at implantation is provided.One and three year post x-rays and ultrasounds are provided.Secondary intervention angiography is provided along with the complaint report.2.Two ziv6-35-125-6-80-ptx stents were implanted across a distal sfa to the mid sfa occlusion.3.At implantation, runoff was initially only imaged to the mid right calf.It was three vessel up to that point.At the secondary intervention, posterior tibial artery (pta) runoff to the foot was confirmed.Anterior tibial artery (ata) and peroneal artery opacification dissipated prior to the foot.Because the right ata equaled the pta at one and three years, runoff was likely at least two vessel into the foot.Ultrasound follow up did not include the calf.4.Although the stents eliminated the occlusion, inflow was limited by at least 50% stenosis of the right cfa and sfa origin.Although the proximal popliteal artery (pa) was narrowed 50%, because this stenosis was not present at the secondary intervention or on follow up ultrasounds, it likely represented spasm.5.No imaging of the cfa or sfa inflow was provided at implantation.The inflow was significantly limited on the diagnostic angiogram.The cfa lumen was narrowed to 3mm and the sfa lumen to 2mm.Because, these stenoses were not as severe on the one year ultrasound, they were likely treated with angioplasty at implantation.6.No stenosis greater than 50% was observed on the one year ultrasound.By three years, the cfa, proximal sfa, and superior end of the proximal ziv6-35-125-6-80-ptx demonstrated 50-99% stenosis on ultrasound.7.The secondary intervention was performed 3.5 years post implantation.The now greater than 75% cfa stenosis and a 70% sfa origin stenoses were treated with endarterectomy; however, this was complicated by a downstream, near occlusive sfa dissection.The dissection was managed by sfa stenting from the distal endarterectomy into the proximal ziv6-35-125-6-80-ptx.The new stents stopped just short of covering the severe, 70%, proximal ziv6-35-125-6-80-ptx in-stent stenosis previously imaged by ultrasound.This stenosis was improved to 40% by angioplasty 8.Mild neointimal hyperplasia, less than 25%, lined the distal ziv6-35-125-6-80-ptx.9.The ziv6-35-125-6-80-ptx stents were normal on x-ray.Impression: 1.Seventy percent in-stent stenosis in the proximal ziv6-35-125-6-80-ptx developing between one and three years is confirmed.The late development and response to angioplasty were consistent with neointimal hyperplasia.The risk of neointimal hyperplasia was increased by progressive inflow limitation from severe progressive atherosclerotic stenosis of the right cfa and sfa origin.2.Progressive atherosclerotic disease and neointimal hyperplasia were aggravated by the reported continued tobacco abuse.Complaint is confirmed as the failure was verified in the image(s).Seventy percent in-stent stenosis in the proximal ziv6-35-125-6-80-ptx developing between one and three years is confirmed.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (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.From the information provided, it is known that the patient had risk factors for restenosis, including coronary artery disease, hypertension, hypercholesterolemia and ongoing tobacco use.The patient exhibited a re-emergence of claudication, which could suggest a progression of the peripheral arterial disease in the superficial femoral artery (sfa).From the image review, the restenosis was likely due to the development of neointimal hyperplasia.The risk of neointimal hyperplasia was increased by progressive inflow limitation from severe progressive atherosclerotic stenosis of the right cfa (common femoral artery) and sfa (superficial femoral artery) origin, which were aggravated by continued tobacco use.However, as the device was not available for evaluation, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.As per the product instruction for use (ifu0093-5), restenosis of the stented artery is listed under potential adverse effects.Document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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 this lot number.Summary: complaint is confirmed as the failure was verified in the image(s).Seventy percent in-stent stenosis in the proximal ziv6-35-125-6-80-ptx developing between one and three years is confirmed.The risk was determined to be moderate (category ii).According to the initial reporter, the patient required balloon angioplasty, stent placement, and a femoral endarterectomy as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted to update the investigation results.Initial mdr required based on the requirement for a surgical intervention (intervention included balloon angioplasty, stent placement, and a femoral endarterectomy.) 12-004 patient (b)(6): occlusion/restenosis of the study lesion, right sfa.On (b)(6) 2014, the patient received one zilver ptx study stent (6 mm x 80 mm) in the right distal sfa.On (b)(6) 2017, the patient reported worsening claudication of the right lower extremity.An ultrasound was performed and revealed stenosis within the study stent.On (b)(6) 2018, the patient had a cta of the right leg which revealed stenosis within the study stent.On (b)(6) 2018, the patient underwent re-intervention due to the occlusion/restenosis within the study lesion (right sfa).Symptoms included worsening claudication.The right rutherford classification was two.Pre-intervention angiography revealed 50-99% stenosis within the study lesion.Intervention included balloon angioplasty, stent placement, and a femoral endarterectomy.Core lab analysis of the angiography is not yet available.The event (occlusion/restenosis) was considered definitely related to the study product.Pre-existing peripheral vascular disease was also noted to have caused or contributed to the event.The site has not provided a response to the question (queried): did the device malfunction or deteriorate in characteristics or performance?.

• 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: 7435473
• MDR Text Key: 105648932
• Report Number: 3001845648-2018-00170
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)141107(10)C1026432
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G24890
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR