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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Ulceration (2116)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The ziv6-35-125-7.0-120-ptx stent of lot number c778405 was implanted in the patient, therefore is not available for evaluation.With the information provided a document based investigation was carried out.It was confirmed that images would not be available to support the complaint investigation.Available information stated that the patient had pre-existing conditions including hypertension, diabetes (type ii), hypercholesterolemia, advanced age and was a previous smoker.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.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.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It may be noted that 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 pta was performed and the patient recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.The ziv6-35-125-7.0-120-ptx stent of lot number c778405 was implanted in the patient, therefore is not available for evaluation.With the information provided a document based investigation was carried out.

Event Description

On (b)(6) 2012: three zilver ptx stents were placed in the patient's right sfa.(all three are same lot #, ziv6-35-125-7.0-120-ptx, lot # c778405).On (b)(6) 2015: restenosis was confirmed where ptx were placed.Ulcer was seen on the patient.On (b)(6) 2015: pta was performed against restenosis.The patient condition has been recovered.As three zilver ptx devices are suspected as involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2016-00047 and 3001845648-2016-00049.

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-7.0-120-ptx stent of lot number c778405 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 and were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: ¿findings: the target lesion was a moderate and severe stenosis of the entire sfa.Calcification was moderate in the proximal sfa and severe in the distal sfa.The profunda femoral branches were severely diseased with occlusion, stenosis, and severe calcification.A prior femoral to distal bypass stump was imaged as well as multiple surgical clips to the distal calf.The occluded bypass distal anastomosis could not be identified.The sfa popliteal junction was angulated and the immediate popliteal artery (pa) moderately dilated relative to a just downstream stenosis.This angiographic appearance is highly suggestive of a popliteal artery aneurysm.The before mentioned popliteal stenosis narrowed the lumen to 2mm.The pa was diseased distally as well measuring 3mm in diameter at the knee and 2mm below the knee.All calf vessels were occluded although the mid and distal calf peroneal artery reconstituted.Near the ankle it shifted posteriorly because it was previously mobilized for a now failed fem distal bypass or it originally primarily supplied the distal posterior tibial artery.This is the most common calf artery normal variant.Total stented length was 29cm.The stents were implanted compressed.The distal stent was deployed to 107mm, the mid to 105mm, and the proximal to 108mm.The stents relieved the sfa stenoses without significant recoil or residual stenosis.Stent diameter was 6mm.The secondary intervention was performed 3 years later.Diffuse neointimal hyperplasia had formed within the stents.No external compression, recoil, or fracture was imaged.Lumen diameter was reduced to 3.3mm in the superior proximal stent and 2.8mm in the mid proximal stent.The middle stent lumen was reduced in 2 locations to 3mm and 3.2mm.The distal stent was narrowed to 3.7mm near the adductor canal and to 3.8mm at the pa junction.An attempt at posterior tibial artery recanalization to the foot failed in the distal calf although collateral perfusion improved.The recanalization may have failed from chronic occlusion as the artery was occluded on the original intervention or also because it terminated in muscular branches and peroneal artery supplied the distal posterior tibial artery.Pa stenosis had significantly progressed since stent implantation with residual lumen diameter of 1.9mm in proximal and distal pa.The tibial peroneal trunk was narrowed to 1.1mm before completely occluding.Iliac artery inflow imaging was not provided although angiography of the common femoral artery at the antegrade access site demonstrated a moderate 50% stenosis.The neointimal hyperplasia in the superior proximal stent was improved with angioplasty.The remainder of the neointimal hyperplasia was not treated or treatment imaging was not provided.Both procedures were performed with contrast rather than carbon dioxide.Given the provided history of renal insufficiency, the patient was likely already on dialysis at implantation.Impression neointimal hyperplasia throughout the stents is confirmed however it was only greater than 50% in the superior proximal stent.This was improved with angioplasty.The rest of the lesions likely went untreated further underscoring their limited significance.The primary cause of foot ulceration was likely the progression of moderate to severe pa stenosis to severe coupled with longstanding occlusion of all calf arteries.The stents were challenged by patient age, severe disease as evidence by the extensive profunda femoral artery disease and prior bypass occlusion, dialysis requiring renal insufficiency, a very long stented segment, a possible pa aneurysm, likely more inflow limitation than just the moderate common femoral artery stenosis, and most significantly severe untreated runoff limitation.Given these constraints the stents performed admirably over 3 years with only the proximal stent developing a greater than 50% stenosis.Significant findings relative to the patient's anatomy were observed.The distal runoff was severely limited.At a minimum inflow was limited by a moderate right cfa stenosis.A pa aneurysm is strongly suggested.These typically destroy distal runoff through chronic small emboli.Significant findings relative to the disease state were observed.The atherosclerotic disease was severe and evidenced by the severe profunda femoral disease and occluded bypass.Significant findings relative to the use of the device were observed.The pa stenosis could have been improved at implantation.It may not have been to avoid emboli if a pa aneurysm was known.Significant findings relative to the design or performance of the device were observed.The stents did develop neointimal hyperplasia.No stent fracture, migration, or compression occurred.¿ the customer complaint can be confirmed as imaging confirmed neointimal hyperplasia was present throughout the stents.Clarification was also requested regarding the compression of the stents at implantation and the following comments were provided: ¿the overlap was 3cm.The stents were either inadvertently or intentionally implanted with some mild forward pressure.There is a belief that particularly in calcified lesions that some more radial force can be obtained by mild stent compression.This idea may have its genesis or at least reinforcement with the supera stent which is available in (b)(4) and the us.This stent is intentional compressed to increased radial force.The amount of compression was not enough to cause kinking or intussusception although long term it could possibly increase the risk of stent fracture but that did not happen either.In this case the restenosis was the only issue.I doubt the compression had any effect on that.In fact given the facts of the case the stents performed as least as well if not better than the alternative treatment of bypass.I did not point this out specifically for this review but the case essentially has an internal control for the alternative therapy, bypass, which was occluded.Although it is not known how long the bypass lasted and the status of the patient¿s disease when the bypass was placed, the stents last 3 year where still salvageable with a secondary intervention in a patient where bypass had failed.That is admirable¿ according to the imaging review, neointimal hyperplasia developed throughout the stents, however, it was only greater than 50% in the superior proximal stent.This was improved with angioplasty; the rest of the lesion was likely untreated.Available information stated that the patient had pre-existing conditions including hypertension, diabetes (type ii), hypercholesterolemia and a history of tobacco use.In addition, according to the independent reviewer, the stents were challenged by patient¿s age, severe disease, dialysis, long stented segment, possible pa aneurysm, inflow and runoff limitation.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.Based on the above, it is unlikely that this event occurred due to device malfunction, the most likely cause of this occurrence was the patient¿s condition.However a definitive root cause cannot be determined.It may be noted that 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 pta was performed and the patient 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 description submitted as follows: on (b)(6) 2012: three zilver ptx stents were placed in the patient's right sfa.(all three are same lot #, ziv6-35-125-7.0-120-ptx, lot # c778405).On (b)(6) 2015: restenosis was confirmed where ptx were placed.Ulcer was seen on the patient.On (b)(6) 2015: pta was performed against restenosis.The patient condition has been recovered.As three zilver ptx devices are suspected as involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2016-00047 and 3001845648-2016-00049.

• 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; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5459685
• MDR Text Key: 38970120
• Report Number: 3001845648-2016-00048
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513539
• UDI-Public: (01)10827002513539(17)140521(10)C778405
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7.0-120-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: 11/17/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/28/2016
• Date Device Manufactured: 06/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention