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 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of (b)(4).Pma/510(k) #p100022/s001.The investigation deals with restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c778925 on the (b)(6) 2017.Reference also reports # 3001845648-2017-00487 and 3001845648-2017-00488.The device was implanted in the patient and therefore will not be available for investigation.With the information provided a document based investigation was carried out.As stated in the complaint file by the originator, images are unavailable for evaluation & no further information will be provided.The patient had the following preexisting conditions: coronary artery disease, hypertension, diabetes (type2), renal failure & previous smoker (current: not).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.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 rest pain 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 c778925.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 c778925.Therefore no action required.Rest pain was observed on the patient.Pta was performed against this on (b)(6) 2017, and the patient's condition was improved.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

This patient had a number of devices place and re-interventions.All will be documented below.Complaints have been raised for all devices resulting in a re-intervention.This report relates to devices placed in the right sfa of the patient and re-intervention occurring (b)(6) 2017.On (b)(6) 2012: three ptx stents were placed in the right sfa of a male patient: ziv6-35-125-6.0-120-ptx lot#c778925, ziv6-35-125-6.0-120-ptx lot#c778925, ziv6-35-125-7.0-120-ptx lot#c777752.On (b)(6) 2012: two ptx stents below were implanted in the left sfa of the patient.Ziv6-35-125-6.0-120-ptx lot#c778922, ziv6-35-125-6.0-120-ptx lot#c778925.On (b)(6) 2017: 100% restenosis was confirmed in the stented lesion in right sfa.Rest pain was observed on the patient.Pta was performed against this on (b)(6) 2017, and the patient's condition was improved.On (b)(6) 2017: restenosis was confirmed in the stented lesion in right sfa.It is unknown if the patient was symptomatic or not.No interventions were conducted against this.The patient's condition was unchanged.Also, restenosis was confirmed in the stented lesion in left sfa.It is unknown if the patient was symptomatic or not.No interventions were conducted against this.The patient's condition was unchanged.This complaint meets fda reportability requirements based on the surgical intervention (pta) carried out due to the occurrence of rest pain after zilver ptx implantation in the lesion in right sfa.As 3 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2017-00487 and 3001845648-2017-00488.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(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.The investigation deals with restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c778925 on the 03-march-2017.Reference also reports # 3001845648-2017-00487 and 3001845648-2017-00488.The device was implanted in the patient and therefore will not be available for investigation.With the information provided a document based investigation was carried out.The patient had the following preexisting conditions: coronary artery disease, hypertension, diabetes (type2), renal failure & previous smoker (current: not).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 secondary intervention, dated (b)(6) 2017, is provided along with the complaint report.All angiography was of the right leg.Angiography was performed completely with carbon dioxide (c02).Image quality was limited because of patient motion and the equipment.Angiography equipment usually requires a specific c02 package to provide high quality imaging.This did not appear to be the case with this procedure.Additionally, no imaging of iliac artery inflow or outflow distal to the popliteal artery (pa) was provided.One attempt at imaging past the tibial/peroneal trunk was limited by patient motion.The three stents extended from the proximal, right pa to the distal, common femoral artery (cfal projecting 1cm into the right cfa.The mid and distal 6mmx120mm stents overlapped 5mm.The mid 6mmx120mm stent and the proximal 7mmx120mm stent overlapped 10mm.The 7mmx120mm stent measured 107mm in length.The mid 6mmx120mm superficial femoral artery (sfa) stent measured 122mm in length.The distal 6mmx120mm stent measured 111mm in length.Total stented length was 310mm.The stents were occluded from the sfa origin through the distal stent, continuing into the pa an additional 25mm.The unstented pa occlusion was 1cm in length, moderately calcified and separated from the distal stent by 1cm.It was not readily crossed.Angioplasty was performed through the stents after the initial lesion crossing attempt failed.A second attempt 12 minutes later succeeded in crossing the occlusion.It cannot be determined whether a de-bulking intervention such as intravascular laser or thrombolysis was performed in the interval or whether it took that long to cross the occlusion.A catheter tip, faintly visible on the subtracted image, suggests a crossing tip catheter rather than an intravascular laser.The pa occlusion was then angioplastied to likely, 4mm.The entire stented segment was also angioplastied to likely 4mm, a modest diameter relative to the 6mm and 7mm stents.No filling defects indicative of thrombus were observed, although thrombus is difficult to discern with c02 angiography.No angiography demonstrating thrombectomy and or thrombolysis was provided.Because the time intervals between angiograms were likely insufficient to perform such interventions, the absence of angiographic evidence of these interventions indicate that they were likely not performed rather than not reported.Although patency through the pa occlusion was restored, diffuse residual stenosis ranging from severe to no more than 3mm in diameter was demonstrated on the limited quality c02 angiography.The vessel would have likely appeared better but still significantly compromised if contrast angiography had been performed.Proximal calf runoff was single vessel through a severely narrowed tibial/ peroneal trunk and proximal posterior artery.Distal to this, patient motion, c02 technique, and or stenosis prevented further vessel identification.Residual stenosis in the mid 6mmx120mm stent and the proximal 7mmx120mm stent indicated neointimal hyperplasia.The distal stent was relatively free of neointimal hyperplasia except at its distal end.The degree of mid stent residual stenosis could not be determined because of limited c02 image quality.Residual stenosis in the proximal stent was 50%.Residual stenosis in the distal stent was likely less than 30%.Impression: absence of flow through the stents is confirmed and although occlusion was likely, it cannot be confirmed primarily because of limited imaging quality and uncertainty as to whether thrombolysis or intravascular laser was performed.Although the stents were narrowed by neointimal hyperplasia and likely occluded with thrombus, sometimes the dead space is filled with un-clotted blood, extremely slow flowing or swirling blood rather than thrombus.The absence of flow through the stents was likely and primarily from the focal pa occlusion near the distal stent.Because the pa occlusion was 1cm distal to the stent end and moderately calcified, it represented atherosclerotic disease progression and not neointimal hyperplasia spillover from the adjacent stent.Although not occlusive, in-stent stenosis from neointimal hyperplasia likely encouraged the pa occlusion.The long-stented length and poor runoff increased the restenosis risk.Durable secondary patency was unlikely given the unresolvable pa stenosis and very limited runoff.This likely explains the relatively conservative approach to the in-stent stenosis.Significant findings relative to the patient's anatomy were not observed.Significant findings relative to the disease state were observed.Distal runoff was so poor that durable long term patency was unlikely even if the in-stent stenosis had been resolved.Progression of atherosclerotic disease resulted in pa occlusion just downstream the stents.Renal insufficiency is confirmed.Significant findings relative to the use of the device were observed.The stented length increased the risk of neointimal hyperplasia.Significant findings relative to the design or performance of the device were observed.Ln-stent stenosis from neointimal hyperplasia was observed in all three stents although the mid and proximal stents were most severely affected.Cause of adverse events was not observed.The complaint is confirmed as the failure was verified in the images.Ln-stent stenosis from neointimal hyperplasia was observed in all three stents although the mid and proximal stents were most severely affected.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.As stated in the imaging review, the long-stented length and poor runoff increased the restenosis risk.Distal runoff was so poor that durable long term patency was unlikely even if the in-stent stenosis had been resolved.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.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 rest pain 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 c778925.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 c778925.Therefore no action required.Rest pain was observed on the patient.Pta was performed against this on (b)(6) 2017, and the patient's condition was improved.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: this patient had a number of devices place and re-interventions.All will be documented below.Complaints have been raised for all devices resulting in a re-intervention.This report relates to devices placed in the right sfa of the patient and re-intervention occurring (b)(6) 2017.(b)(6) 2012: three ptx stents were placed in the right sfa of a male patient.Ziv6-35-125-6.0-120-ptx, lot#c778925.Ziv6-35-125-6.0-120-ptx, lot#c778925.Ziv6-35-125-7.0-120-ptx, lot#c777752.(b)(6) 2012: two ptx stents below were implanted in the left sfa of the patient.Ziv6-35-125-6.0-120-ptx, lot#c778922.Ziv6-35-125-6.0-120-ptx, lot#c778925.(b)(6) 2017: 100% restenosis was confirmed in the stented lesion in right sfa.Rest pain was observed on the patient.Pta was performed against this on (b)(6) 2017, and the patient's condition was improved.(b)(6) 2017: restenosis was confirmed in the stented lesion in right sfa.It is unknown if the patient was symptomatic or not.No interventions were conducted against this.The patient's condition was unchanged.Also, restenosis was confirmed in the stented lesion in left sfa.It is unknown if the patient was symptomatic or not.No interventions were conducted against this.The patient's condition was unchanged.This complaint meets fda reportability requirements based on the surgical intervention (pta) carried out due to the occurrence of rest pain after zilver ptx implantation in the lesion in right sfa.As 3 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2017-00487 and 3001845648-2017-00488.

• 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: 6983329
• MDR Text Key: 90424111
• Report Number: 3001845648-2017-00486
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140426(10)C778925
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• 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: 10/27/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2017
• Date Device Manufactured: 06/21/2012
• 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: 82 YR