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 Occlusion (1984); Ulceration (2116)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Pma/510(k) #p100022/s001.The ziv6-35-125-6.0-120-ptx stent of lot number cf766268 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.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: 1.Secondary intervention angiography performed almost five years after stent implantation is provided along with the complaint report.2.Three zilver ptx stents were implanted from 2cm distal to the left sfa origin through the above knee popliteal artery (pa) to the level of the inferior patella.Each stent overlapped 1cm for a total stented length of 28cm.The proximal stent was the 6x60mm stent.3.Inflow was limited by a chronic dual channel left common femoral artery (cfa) dissection, reduced to a 2.7mm lumen.No normal left cfa was present to determine reference vessel diameter (rvd).Given the sfa was stented with 6 mm stents, using 6mm as a conservative estimate of left cfa reference vessel diameter, the stenosis was 55% maximal diameter.Additionally, upstream a stent had been implanted in the left external iliac artery.Imaging of inflow proximal to the distal left external iliac artery was not provided but was not sluggish enough to suggest a significant proximal stenosis.4.The first centimeter of sfa was moderately stenotic but patent.The centimeter just proximal to the stents was occluded.The occlusion continued through the stents, through the entire pa and into the proximal anterior tibial artery (ata).The posterior tibial and peroneal arteries were completely occluded.Some difficulty passing a wire through the proximal stent (6mmx60mm) and the overlap of the two distal (6mmx120mm) stents was observed.5.Laser atherectomy/embolectomy through the entire occlusion and stents was performed first followed by 3mm balloon angioplasty of the pa and proximal ata occlusion and then 5mm angioplasty of the stented segment.Thin soft tissue separating the stent and inflated balloon was observed, indicating no more than moderate residual neointimal hyperplasia.These interventions established a very narrow channel through the stents and the pa and ata artery occlusion.6.The entire stented segment was angioplastied to 6mm.This restored the stent lumen to patent with mild residual stenosis; however the pa and ata outflow had re-occluded.A second 3 mm angioplasty restored a narrow channel through the pa and ata.The pa lumen was particularly poor at 1.4mm in diameter.2mm angioplasty of the entire ata and dorsal pedis artery was then performed.This shortened but did not eliminate a severe distal ata stenosis.7.A final completion angiogram was not provided.Impression: 1.Stent occlusion at almost five years post implantation was confirmed.Given the poor outcome of the pa and ata occlusion particularly in the above knee pa, the stent occlusion was likely primarily thrombotic and secondary to pa and ata occlusion.The degree of neointimal hyperplasia vs.Acute thrombus cannot be quantitated.However qualitatively, based on the difficulty with wire advancement and the amount of tissue between the stent and balloon during angioplasty, no more than moderate in-stent stenosis from neointimal hyperplasia was present in the stents.2.Patency was also limited by at least moderate cfa inflow stenosis and severe outflow limitation from occlusion of the tibial peroneal trunk, the peroneal artery and the posterior tibial artery.3.Significant findings relative to the patient's anatomy were observed.Inflow was limited by at least a 55% left cfa maximal diameter stenosis.Outflow was completely occluded until the proximal ata.4.Significant findings relative to the disease state were not observed.5.Significant findings relative to the use of the device were not observed.6.Significant findings relative to the design or performance of the device were observed.The stents developed no more than moderate neointimal hyperplasia.The severity was unlikely enough to be the primary cause of stent occlusion.The stents likely thrombosed secondary to occlusion of the pa and proximal ata distal to the stents.7.Cause of adverse events was not observed.Based on the imaging review the customer complaint is confirmed.A moderate in-stent stenosis from neointimal hyperplasia was present in the stents.Thrombosis is also confirmed, as stated in the image review the stent occlusion was likely primarily thrombotic and secondary to pa and ata occlusion.The degree of neointimal hyperplasia vs.Acute thrombus cannot be quantitated.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 root cause of this event cannot be determined at this time.It may be noted that as per the packaging insert, restenosis of the stented artery is a known potential adverse event associated with the 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.Upon review of complaints, this failure mode has occurred previously with the lot number cf766268.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 cf766268.Pta was performed against the restenosis.The condition of the patient was improved.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On(b)(6) 2012 three ptx stents below were placed in left sfa of the patient: ziv6-35-125-6.0-120-ptx cf766268, ziv6-35-125-6.0-120-ptx cf766268, ziv6-35-125-6.0-60-ptx cf766313.On (b)(6) 2017: 100% restenosis in the stented lesion was confirmed.Ulcer was observed on the patient.On (b)(6) 2017: pta was performed against the restenosis.The condition of the patient was improved.As 3 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also reports # 3001845648-2017-00244 and 3001845648-2017-00245.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6676360
• MDR Text Key: 78669443
• Report Number: 3001845648-2017-00242
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140311(10)CF766268
• 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
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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: 06/29/2017
• Event Location: Hospital
• Date Manufacturer Received: 06/01/2017
• Date Device Manufactured: 05/10/2012
• 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 Age: 81 YR