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 Problem Reocclusion (1985)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s001.This investigation captures the restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c779529 on the 04-jan-2017.Reference also reports # 3001845648-2017-00493, 3001845648-2017-00495 and 3001845648-2017-00496.The ziv6-35-125-6.0-120-ptx stent of lot number c779529 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator in the complaint file that no further information will be provided and there are no images available for review.The patient had the following pre-existing conditions at the time of the procedure: hypertension and renal disease.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.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 packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.In addition worsened claudication is also listed as a potential adverse event associated with the placement in this device as per the packaging insert.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 c779529.However based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c779529.Pta against the restenosis was conducted.The condition of the patient was recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2011, four ptx stents below were placed in the left sfa of a female patient.Ziv6-35-125-6.0-120-ptx lot#c778921, ziv6-35-125-6.0-120-ptx lot#c779529, ziv6-35-125-6.0-120-ptx lot#c779529, ziv6-35-125-6.0-60-ptx lot#c777740.On (b)(6) 2017, 100% restenosis of the stented lesion was confirmed.Intermittent claudication was observed on the patient.On (b)(6) 2017, pta against the restenosis was conducted.The condition of the patient was recovered.On (b)(6) 2017, restenosis of the stented lesion was confirmed.It is unknown if the patient was symptomatic or not.No interventions were conducted against this.The physician determined to take wait and see approach.The patient's condition was unchanged.As 4 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2017-00493, 3001845648-2017-00495 and 3001845648-2017-00496.

Manufacturer Narrative

(b)(4).Exemption number: e2016031 importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s001.This follow up mdr is being submitted due to the receipt and review of images relating to this event.This investigation captures the restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c779529 on the (b)(6) 2017.Reference also reports # 3001845648-2017-00493, 3001845648-2017-00495 and 3001845648-2017-00496.The ziv6-35-125-6.0-120-ptx stent of lot number c779529 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 at the time of the procedure: hypertension & renal disease.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: findings: angiography from an (b)(6) 2016 secondary intervention, six years after implantation and then from a repeat secondary intervention, dated (b)(6) 2017, is provided along with the complaint report.Nine total stents are present.It cannot be determined whether the complaint stents were the initial stents or whether they were placed inside of pre-existing stents.A wire fragment at the inferior end of a 12cm stent was trapped by the most distal stent.The most distal stent measured 6cm in length and extended into the above knee popliteal artery (pa).The total stented length was 320mm.The complaint stents would have covered 360mm if each was overlapped 1cm.Consequently, greater than 1cm overlap was present between some of the complaint stents.The proximal stents extended into the mid left common femoral artery (cfa) and were double layered in the cfa.One of these stents was 6cm long.A segment of proximally overlapped stents match a scenario where three 12cm stents were implanted from distal to proximal with extension into the mid cfa.The proximal and mid stents would have been overlapped 5cm while the mid and distal stents would have overlapped 1cm.The 6cm complaint stent would have been implanted last to trap the wire fragment.Angiography performed with carbon dioxide and limited contrast volumes indicate significant renal insufficiency.The right superficial femoral artery (sfa) and a right sfa stent were occluded.The (b)(6) 2016 intervention required angioplasty, laser atherectomy, and stenting of a severely narrowed and heavily calcified left common and external iliac artery with extension into the proximal cfa.The entire left sfa and pa stented segment was occluded.Only the cfa segment remained patent into the profunda femoral artery.The occlusion extended 2cm distally into the above knee pa.Single vessel anterior tibial artery runoff was present into the dorsal pedis artery.Difficulty crossing the occlusion indicates that significant neointimal hyperplasia was present.Thrombus would have been rapidly crossed.The occlusion was treated with laser atherectomy and angioplasty.Completion angiography through the proximal and mid sfa was not provided.Diffuse moderate and moderate to severe residual stenosis were present on completion angiography through the distal sfa and popliteal artery with spiral dissection involving the previously occluded pa segment adjacent to the stents.Reocclusion of the entire sfa and previously occluded pa was demonstrated on (b)(6) 2017.The entire occlusion was treated as before with laser atherectomy and angioplasty.The outcome was significantly better with diffuse residual stenosis less than and equal to 50%.One vessel continuous runoff into the foot via the anterior tibial artery was reestablished.Impression: stent occlusion and reocclusion is confirmed however cannot be determined that it involved the complaint stents.Either the complaint stents were implanted in preexisting stents or they were completely covered during earlier secondary interventions.The most likely scenario was that the complaint stents were implanted in the native artery and then treated with one or more secondary interventions for which no information was provided.In this scenario, the complaint stents would not be related to these two occlusive episodes because they were completely covered with additional stents.The less likely scenario was that the stents had been placed in preexisting stents during a secondary intervention.In this scenario, the stents would have kept the patient asymptomatic for approximately six years and then occluded.Given the extent of disease, the inflow and outflow limitations, and the comorbidity of renal insufficiency, this is unlikely.Significant findings relative to the patient's anatomy were observed.Inflow was severely limited prior to the first occlusion and not imaged at the second.Runoff was single vessel.Significant findings relative to the disease state were observed.Severe atherosclerotic disease was confirmed.Renal insufficiency was confirmed.Significant findings relative to the use of the device were observed.The 11/22/16 secondary intervention result was unlikely to provide even short term patency.Significant findings relative to the design or performance of the device were observed.Although it cannot be determined whether the complaint occlusions and provided imaging are related to the complaint stents, the complaint stents developed significant restenosis at some point in time.Cause of adverse events was not observed.Stent occlusion and reocclusion is confirmed however cannot be determined that it involved the complaint stents.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 a definitive root cause of this event cannot be determined at this time.The potential cause of restenosis is not directly related to the design of the device and therefore cannot be reduced further by design.Arterial injury is an unavoidable outcome from the angioplasty/stenting procedure.Angioplasty alone can cause arterial injury leading to restenosis.Therefore restenosis caused by the angioplasty/stenting procedure poses no greater risk than angioplasty alone.Clinical study results indicate that the risk of restenosis when the zilver ptx stent is used is significantly lower than when angioplasty alone is performed, or when stenting with a bare zilver stent is performed.As determined by risk/benefit analysis the clinical benefits of the zilver ptx drug-eluting stent system outweigh the risks to the patient.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 packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.In addition worsened claudication is also listed as a potential adverse event associated with the placement in this device as per the packaging insert.The packaging insert also states the following ¿do not implant more than 3500 ¿g of total paclitaxel amount.[the effect of implanting stents with more than 3500 ¿g total paclitaxel in a patient has not been clinically evaluated.]¿ 4 stents were implanted in this patient as outlined above, which amounted to a total of 3861¿g implanted.The imaging review stated the following: "the complaint stents would have covered 360mm if each was overlapped 1cm.Consequently, greater than 1cm overlap was present between some of the complaint stents." the packaging insert recommends the following: "if placements of multiple stents are required to cover the length of the lesion, deploy the stents so that the ends of the stents overlap (in clinical trial, approximately 5mm of overlap was recommended)." 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 c779529.However based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c779529.Pta against the restenosis was conducted.The condition of the patient was recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

This follow up mdr is being submitted due to the receipt and review of images relating to this event.Initial report details: on (b)(6) 2011 four ptx stents below were placed in the left sfa of a female patient.Ziv6-35-125-6.0-120-ptx lot#c778921; ziv6-35-125-6.0-120-ptx lot#c779529; ziv6-35-125-6.0-120-ptx lot#c779529; ziv6-35-125-6.0-60-ptx lot#c777740.On (b)(6) 2017 100% restenosis of the stented lesion was confirmed.Intermittent claudication was observed on the patient.On (b)(6) 2017 pta against the restenosis was conducted.The condition of the patient was recovered.On (b)(6) 2017 restenosis of the stented lesion was confirmed.It is unknown if the patient was symptomatic or not.No interventions were conducted against this.The physician determined to take wait and see approach.The patient's condition was unchanged.As 4 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2017-00493, 3001845648-2017-00495 and 3001845648-2017-00496.

• 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: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6990444
• MDR Text Key: 90676237
• Report Number: 3001845648-2017-00494
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140524(10)C779529
• Combination Product (y/n): N
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-120-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: 10/31/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/29/2017
• Date Device Manufactured: 06/22/2012
• 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
• Patient Age: 78 YR