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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Reocclusion (1985); Stenosis (2263); Stenosis (2263); Claudication (2550); Claudication (2550)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report based on the surgical intervention carried out as a result of restenosis occurring while a zilver ptx stent was indwelling.The ziv6-35-125-6.0-120-ptx was implanted to the pt, therefore is not available for eval.With the info provided, a document based investigation was carried out and is based on customer testimony.According to complaint info provided, worsened claudication was observed on the pt.It can be noted that worsened claudication indicates progression of peripheral artery disease and can also be associated with 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 provides an inflammatory response that leads to (or amplifies) and 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 due to lack of imaging.No other comments can be made.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 mfg records revealed no discrepancies that could have contributed to this complaint.According to info provided, pta was performed against the restenosis and the pt's condition recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012, two ptx devices were implanted (ziv6-35-125-6.0-120-ptx/c793706) in the left upper sfa.In early (b)(6) 2015, restenosis (100%) were ptx were placed was confirmed and worsened claudication was observed in the pt.On (b)(6) 2015, pta was performed against the restenosis and the pt's condition recovered.There have been no adverse effect to the pt.This report addresses the second device reported.An add'l separate report will be submitted in relation to the first device reported.Report ref number: 3001845648-2015-00073.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The ziv6-35-125-6.0-120-ptx of lot number c793706 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation.These were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: "findings: angiography from implantation (b)(6) 2012 was provided.The target lesion was an occluded proximal left sfa 10 cm smart stent and contiguous mid sfa occlusion.The 12cm zilver ptx was implanted a centimetre proximal, within, and one centimetre distal the 10cm smart stent.The second zilver ptx stent was then implanted overlapping the proximal zilver ptx stent by 3cm.Stent constraint upon deployment revealed mild stenosis from neointimal hyperplasia throughout the smart stent with superimposed moderate stenosis in the distal smart stent and mild stenosis in the distal sfa with a superimposed moderate to severe stenosis at the adductor canal.Post stenting angioplasty, the neointimal hyperplasia mild constrained the zilver ptx stents inside the smart stent.A completion angiogram with contrast demonstrated poor distal runoff.From proximal to distal, the distal sfa and above knee pa were mild to moderately narrow (25-50%) with a moderate to severe (50-75%) knee joint pa stenosis.The below knee pa was diffusely mild to moderately narrowed.The tibial peroneal trunk was moderate to severe narrow.The peroneal artery was occluded.The proximal anterior tibial artery (at) was focally occluded.It reconstituted in the mid-calf and remained patent to the foot although it was diffusely moderate to severely narrow throughout.Angiography from the third re-intervention (b)(6) 2015 was provided.C02 angiography from the left cia revealed no left external or common femoral artery stenosis however there was no flow into the left sfa stents.Although no imaging inside the stented segment before angioplasty was provided.Upon angioplasty similar moderate neointimal hyperplasia was evident in the distal sfa stent.Post angioplasty c02and contrast angiography was performed through the stent.The sfa stents were patent on contrast angiography and was falsely occluded on co2 angiography.After angioplasty mild diffuse stenosis from neointimal hyperplasia was present throughout the stents except in the superior portion of the distal zilver ptx stent which was moderately narrow just inferior its junction with the proximal zilver ptx stent.Imaging of the distal runoff to the proximal calf demonstrated for the first time a high left pt origin.Just inferior the pt origin, a 65% pa stenosis was demonstrated.A 50% pa at the patella was also present.No imaging demonstrating angioplasty of these lesions was provided.Perhaps a balloon long enough to reach was not available.The distal anastomotic stenosis of a right femoral popliteal artery bypass was recurrent and again angioplastied during the intervention.Impression: although c02 angiography demonstrated stent occlusion at each re-intervention, this was likely false.The stents were only severely narrowed.First, the poor distal runoff was still intact after three re-interventions despite no thrombolysis.Had the stents been thrombosed, the runoff would have been occluded by emboli.Second on back to back contrast and c02 angiography, contrast demonstrated patency where c02 demonstrated occlusion.The proximal zilver ptx was never shown to be more than mildly narrow from neointimal hyperplasia.The distal zilver ptx stent demonstrated three occurrences of at least moderate to severe stenosis from neointimal hyperplasia.Numerous risk factors for neointimal hyperplasia and recurrence were present including global severe vascular disease, the presence of pre implantation in-stent occlusion, long lesion and stented segment length, unaddressed popliteal stenosis, poor runoff, left common iliac inflow limitation, inflow competition from the right leg, and numerous medical factors listed in the complaint report.The overall burden of vascular disease was very high.The chronic right iliac artery and sfa occlusion, the severe left subclavian stenosis, and the repeated occurrence of right fem-pop bypass distal anastomotic stenosis are evidence of this.¿ based on the imaging review, mild diffuse stenosis from neointimal hyperplasia was present throughout the stents except in the superior region of the distal stent which was moderately narrowed.The independent reviewer concluded that the proximal stent was only mildly narrowed from neointimal hyperplasia and the distal stent demonstrated moderate to severe occurrences of stenosis from neointimal hyperplasia.According to the independent reviewer, various risk factors for neointimal hyperplasia and recurrence were present, which may have contributed to the events including: global severe vascular disease, pre-implantation stent occlusion, long lesion and stented segment length, unaddressed popliteal stenosis, poor runoff, left common iliac inflow limitation, inflow competition from the right leg, and numerous medical factors.The customer complaint can be confirmed as imaging revealed stenosis throughout the stents.According to complaint information provided, worsened claudication was observed on the patient.It can be noted that worsened claudication indicates progression of peripheral artery disease and can also be associated with 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.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, pta was performed against the restenosis and the patient's condition recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the receipt and review of images relating to this event: initial event description as follows: on (b)(6) 2012, two ptx devices were implanted ( ziv6-35-125-6.0-120-ptx / c793706) in the left upper sfa.Early (b)(6) 2015, restenosis (100%) where the ptx devices were placed was confirmed and worsened claudication was observed in the patient.On (b)(6) 2015, pta was performed against the restenosis and the patient's condition recovered.This report addresses the first device reported.An additional separate report will be submitted in relation to the second device reported- report reference number: 3001845648-2015-00073.

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report based on the surgical intervention carried out as a result of restenosis occurring while a zilver ptx stent was indwelling.The ziv6-35-125-6.0-120-ptx was implanted to the pt, therefore is not available for eval.With the info provided, a document based investigation was carried out and is based on customer testimony.According to complaint info provided, worsened claudication was observed on the pt.It can be noted that worsened claudication indicates progression of peripheral artery disease and can also be associated with 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 provides an inflammatory response that leads to (or amplifies) and 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 due to lack of imaging.No other comments can be made.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 mfg records revealed no discrepancies that could have contributed to this complaint.According to info provided, pta was performed against the restenosis and the pt's condition recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012, two ptx devices were implanted (ziv6-35-125-6.0-120-ptx/c793706) in the left upper sfa.In early (b)(6) 2015, restenosis (100%) were ptx were placed was confirmed and worsened claudication was observed in the pt.On (b)(6) 2015, pta was performed against the restenosis and the pt's condition recovered.There have been no adverse effect to the pt.This report addresses the second device reported.An add'l separate report will be submitted in relation to the first device reported.Report ref number: 3001845648-2015-00073.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 4687755
• MDR Text Key: 49681153
• Report Number: 3001845648-2015-00074
• Device Sequence Number: 0
• Product Code: NIU
• 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: 03/11/2015,09/22/2015
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C793706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR