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

Model Number G24890

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information pertaining to contact office as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).This investigation deals with restenosis of ziv6-35-125-6-80-ptx stent of lot number c1026030, noted on the (b)(6) 2017.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00622.The ziv6-35-125-6-80-ptx stent of lot number c1026030 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.The patient had the following pre-existing conditions: history of coronary artery disease, hypertension, carotid disease, hypercholesterolemia, and smoking (quit).Imaging is currently pending for this patient.The investigation will be updated following the receipt of the imaging review.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.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 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 as no imaging was available at the time of investigation, a definitive root cause of this event cannot be determined at this time.In addition worsened claudication was also observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.It may be noted that the instructions for use lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.Worsened claudication is also listed as a potential adverse event in the instructions for use following the placement of this device.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use for 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.Upon review of complaints, this failure mode has occurred previously with the lot number c1026030 under (b)(4) for the same patient/stent.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1026030.A secondary intervention of balloon angioplasty with a drug coated balloon was required as a result of this occurrence.The patient remains in the study.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

(b)(4), patient (b)(6): occlusion/restenosis of the study lesion, right proximal sfa.On (b)(6) 2014 the patient received two zilver ptx study stents (6 mm x 100 mm; 6 mm x 80 mm) in the right proximal sfa.On (b)(6) 2016 (734 days post-procedure), the two-year ultrasound and follow-up assessment were completed.The ultrasound revealed 50-99% stenosis proximal to the study lesion and patency within and distal to the study lesion.The core lab analysis revealed patency proximal to, within, and distal to the study lesion.The patient complained of lifestyle limiting claudication with symptoms worsening the last 2-3 months.The right and left abis were 0.84 and 0.9, respectively.Right and left rutherford classifications were two and one, respectively.The patient returned for peripheral angiography on (b)(6) 2016 (762 days post-procedure ¿ previously reported in pr # (b)(4)).Angiography revealed 50-99% diameter stenosis within the study lesion.Percutaneous intervention included balloon angioplasty and cutting balloon.Intervention was considered successful with less than 50 % diameter residual stenosis remaining.Pre-intervention angiography has not been provided.Core lab analysis is not available.The investigator noted that the event (occlusion/restenosis) was possibly related to the study product and not related to the study procedure.Pre-existing pad (peripheral arterial disease) was also noted to have caused or contributed to the event.On (b)(6) 2017 (1163 days post-procedure), the patient sought treatment for worsening claudication and an ultrasound revealed evidence of a restenosis/occlusion of the study lesion (imaging read not available).The right and left abi was 0.6.The rutherford classification was not performed.On (b)(6) 2017 (1175 days post-procedure), the pre-intervention angiography revealed 50-99% stenosis in the study lesion.Percutaneous intervention included a balloon angioplasty with a drug coated balloon.Intervention was considered successful with less than 50 % diameter residual stenosis remaining.Pre-intervention angiography has not been provided.Core lab analysis is not available.The investigator noted that the event (occlusion/restenosis) was possibly related to the study product and not related to the study procedure.Pre-existing pad (peripheral vascular disease) was also noted to have caused or contributed to the event.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00622.

Manufacturer Narrative

Pma/510(k)#: p100022/s001.(b)(4).Exemption number: e2016031.(b)(4).This follow up report is being submitted based on the receipt of images relating to the patient.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This follow up report is being submitted based on the receipt of images relating to the patient.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.(b)(6) occlusion/restenosis of the study lesion, right proximal sfa on (b)(6) 2014 the patient received two zilver ptx study stents (6 mm x 100 mm; 6 mm x 80 mm) in the right proximal sfa.On (b)(6) 2016 (734 days post-procedure), the two-year ultrasound and follow-up assessment were completed.The ultrasound revealed 50-99% stenosis proximal to the study lesion and patency within and distal to the study lesion.The core lab analysis revealed patency proximal to, within, and distal to the study lesion.The patient complained of lifestyle limiting claudication with symptoms worsening the last 2-3 months.The right and left abis were 0.84 and 0.9, respectively.Right and left rutherford classifications were two and one, respectively.The patient returned for peripheral angiography on (b)(6) 2016 (762 days post-procedure ¿ previously reported in (b)(4).Angiography revealed 50-99% diameter stenosis within the study lesion.Percutaneous intervention included balloon angioplasty and cutting balloon.Intervention was considered successful with less than 50 % diameter residual stenosis remaining.Pre-intervention angiography has not been provided.Core lab analysis is not available.The investigator noted that the event (occlusion/restenosis) was possibly related to the study product and not related to the study procedure.Pre-existing pad (peripheral arterial disease) was also noted to have caused or contributed to the event.On (b)(6) 2017 (1163 days post-procedure), the patient sought treatment for worsening claudication and an ultrasound revealed evidence of a restenosis/occlusion of the study lesion (imaging read not available).The right and left abi was 0.6.The rutherford classification was not performed.On (b)(6) 2017 (1175 days post-procedure), the pre-intervention angiography revealed 50-99% stenosis in the study lesion.Percutaneous intervention included a balloon angioplasty with a drug coated balloon.Intervention was considered successful with less than 50 % diameter residual stenosis remaining.Pre-intervention angiography has not been provided.Core lab analysis is not available.The investigator noted that the event (occlusion/restenosis) was possibly related to the study product and not related to the study procedure.Pre-existing pad (peripheral vascular disease) was also noted to have caused or contributed to the event.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00622.

Manufacturer Narrative

Pma/510(k)#: p100022/s001 device evaluation there are currently 05 complaint files for this patient: pr (b)(4) ¿ restenosis of ziv6-35-125-6-100-ptx stent of lot number c1005806, noted on the (b)(6) 2016.Pr(b)(4) ¿ restenosis of ziv6-35-125-6-80-ptx stent of lot number c1026030, noted on the (b)(6) 2016.Pr(b)(4)¿ restenosis of ziv6-35-125-6-100-ptx stent of lot number c1005806, noted on the (b)(6)2017.Pr (b)(4) ¿ restenosis of ziv6-35-125-6-80-ptx stent of lot number c1026030, noted on the (b)(6) 2017.Pr (b)(4)¿ stent fracture of ziv6-35-125-6-80-ptx stent of lot number c1026030 on the (b)(6) 2019.This investigation deals with restenosis of ziv6-35-125-6-80-ptx stent of lot number c1026030, noted on the (b)(6) 2017.The ziv6-35-125-6-80-ptx device of lot number c1026030 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 prior to distribution ziv6-35-125-6-80-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for ziv6-35-125-6-80-ptx of lot number c1026030 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number.No action is required as the failure mode occurred twice within the same patient as part of this study.Restenosis is also listed as a known potential adverse event within the ifu and patient pre-existing conditions can contribute to the event.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1026030.Restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0093-5).There is no evidence to suggest that 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.Progressive, significant in-stent stenosis consistent with neointimal hyperplasia was indicated on ultrasound and confirmed angiographically.The significant proximal stenosis and a downstream borderline significant stenosis were already present at 12 months.Additional distal stenoses between 12 and 24 months were required to produce symptoms.2.Both stents developed significant stenosis from neointimal hyperplasia.The significant stenoses developed in the mid 10cm proximal stent and in the superior and inferior ends of the 8cm distal stent.3.Progressive atherosclerotic disease in the popliteal artery and anterior tibial artery resulted in new significant outflow limitation.4.Pr(b)(4) (ccr1863) and pr(b)(4) and (b)(4) (ccr1384) pertain to a complaint of study lesion restenosis.Although in-stent stenosis was confirmed on the first additional intervention, it did not recur and was not confirmed on the second additional intervention.The progressive and then recurrent outflow stenoses despite widely patent stents indicate that the initial outflow lesions were secondary to atherosclerotic disease progression independent of the initial in-stent stenosis.5.The complaint of ziv6-35-125-6-80-ptx type i fracture (pr(b)(4) is confirmed.Its development where the stent was likely over expanded at the 24-month additional intervention and its stability at 60 months indicate that it was likely related to angioplasty and not repetitive motion fatigue.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions and/or an adverse event as a result of the procedure.From the information provided it is known that the patient had a medical history of coronary artery disease, hypertension, carotid disease, hypercholesterolemia, atherosclerotic disease and smoking (quit).It is possible that the patient¿s pre-existing conditions caused and/or contributed to the event of restenosis.Restenosis is a common adverse event of endovascular procedures and is listed as a known potential adverse event within the ifu.Restenosis 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 surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.Summary: complaint is confirmed as the failure was verified in the image(s).According to the initial reporter, the patient required balloon angioplasty with a drug coated balloon was required as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

12-004, patient (b)(6) : occlusion/restenosis of the study lesion, right proximal sfa on (b)(6) 2014 the patient received two zilver ptx study stents (6 mm x 100 mm; 6 mm x 80 mm) in the right proximal sfa.On (b)(6) 2016 (734 days post-procedure), the two-year ultrasound and follow-up assessment were completed.The ultrasound revealed 50-99% stenosis proximal to the study lesion and patency within and distal to the study lesion.The core lab analysis revealed patency proximal to, within, and distal to the study lesion.The patient complained of lifestyle limiting claudication with symptoms worsening the last 2-3 months.The right and left abis were 0.84 and 0.9, respectively.Right and left rutherford classifications were two and one, respectively.The patient returned for peripheral angiography on (b)(6) 2016 (762 days post-procedure ¿ previously reported in pr #(b)(4).Angiography revealed 50-99% diameter stenosis within the study lesion.Percutaneous intervention included balloon angioplasty and cutting balloon.Intervention was considered successful with less than 50 % diameter residual stenosis remaining.Pre-intervention angiography has not been provided.Core lab analysis is not available.The investigator noted that the event (occlusion/restenosis) was possibly related to the study product and not related to the study procedure.Pre-existing pad (peripheral arterial disease) was also noted to have caused or contributed to the event.On (b)(6) 2017 (1163 days post-procedure), the patient sought treatment for worsening claudication and an ultrasound revealed evidence of a restenosis/occlusion of the study lesion (imaging read not available).The right and left abi was 0.6.The rutherford classification was not performed.On (b)(6) 2017 (1175 days post-procedure), the pre-intervention angiography revealed 50-99% stenosis in the study lesion.Percutaneous intervention included a balloon angioplasty with a drug coated balloon.Intervention was considered successful with less than 50 % diameter residual stenosis remaining.Pre-intervention angiography has not been provided.Core lab analysis is not available.The investigator noted that the event (occlusion/restenosis) was possibly related to the study product and not related to the study procedure.Pre-existing pad (peripheral vascular disease) was also noted to have caused or contributed to the event.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00622.

• 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; national technology park; limerick
• MDR Report Key: 7150478
• MDR Text Key: 95900114
• Report Number: 3001845648-2017-00623
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)141107(10)C1026030
• Combination Product (y/n): N
• 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
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2014
• Device Model Number: G24890
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C1026030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR