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

Catalog Number ZIV6-35-125-5.0-40-PTX-CI

Device Problem Occlusion Within Device (1423)

Patient Problem Claudication (2550)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001 (similar device).The ziv6-35-125-5.0-40-ptx-ci device of lot number c969444 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 (b)(4) and the following comments were provided by the independent reviewer: findings: angiography from stent implantation is provided along with the complaint report.The lesion was a 2cm long, non-calcified, distal left sfa to proximal left popliteal artery occlusion just inferior to the expected location of the left adductor canal.The lesion was recanalized and then stented with a 5x40mm zilver ptx stent.5mm of the zilver stent projected superior to the occlusion and 15mm inferior.The post stent angioplasty balloon diameter measured 5mm rather than 4mm.The proximal half of the stent expanded to 4.3mm while the distal half expanded to 5mm.Proximal reference vessel diameter (rvd) was 5.0mm and distal rvd 4.7mm.Inflow was normal until just proximal to the stent where a 40% adductor canal stenosis was left untreated.The left posterior tibial artery was occluded until the distal calf where it was reconstituted by the peroneal artery.The anterior tibial artery was occluded just distal to its origin through the dorsal pedis artery.The peroneal artery origin was narrowed 30%.Impression: the stent was implanted in the left distal sfa/proximal popliteal artery without addressing a 40% inflow stenosis just proximal.This increased the probability of significant downstream in stent stenosis.The stenosis could have been easily eliminated with implantation of a 60mm rather than 40mm long stent.Poor runoff also increased the probability of in-stent stenosis.Significant findings relative to the patient's anatomy were observed.Inflow just proximal to the stent was limited by an untreated 40% left sfa stenosis.Runoff was limited.The peroneal artery reconstituted the posterior tibial artery just proximal to the ankle.Significant findings relative to the disease state were not observed.Significant findings relative to the use of the device were observed.A 40% stenosis just proximal to the stent was left untreated.Significant findings relative to the design or performance of the device were not observed.Cause of adverse events was not observed.Based on the imaging review, the customer complaint of restenosis was confirmed.The stent was implanted in the left distal sfa/proximal popliteal artery without addressing a 40% inflow stenosis just proximal.This increased the probability of significant downstream in stent stenosis.The stenosis could have been easily eliminated with implantation of a 60mm rather than 40mm long stent.Poor runoff also increased the probability of in-stent stenosis.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 as no imaging was available at the time of investigation, a definitive root cause of this event cannot be determined at this time.In addition worsened claudication and rest pain were also observed on the patient.It can be noted that these symptoms indicate progression of peripheral artery disease and can also be associated with the restenosis process.It may be noted that the site marked no to the following question: did the device malfunction or deteriorate in characteristics or performance? the site indicated that this was not a serious adverse event (sae).As per the instructions for use, restenosis of the stented artery is a known potential adverse event associated with the placement of this device.Rest pain and claudication are also listed as potential adverse event associated with the placement of this device as per the instructions for use.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 c969444.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.Treatment included a change of medication.No other device related adverse events have been reported.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

(b)(6) ¿ worsened claudication/rest pain definitely related to the device.On (b)(6) 2015, the patient underwent pre-dilatation of study lesion with one inflation of a 4.0 x 40 mm balloon.One 5.0 mm x 40 mm (lot # c969444, serial # (b)(4)) zilver® ptx® v study stent was placed in the left popliteal artery via contralateral access.The implanting physician noted no difficulty using the stent or the delivery system.No non-study stents were used to treat the study lesion.Post-stent dilatation was performed with one inflation of a 4.0 mm x 40 mm balloon.At the conclusion of the case, there was no residual stenosis remaining in the study lesion.The post-procedural abi in the study leg was 1.05.On (b)(6) 2015, the patient was discharged from the hospital taking talcom and aspirin.On (b)(6) 2015, the six-month follow-up clinical assessment was performed.The study leg abi was 0.42 and the rutherford classification was two.On an unknown date in (b)(6) 2015, the patient experienced worsened claudication/rest pain in the left lower limb.Treatment included a change of medication.The investigator evaluated this event and determined it was ¿definitely¿ related to the study product and procedure.On (b)(6) 2015, the twelve-month follow-up clinical assessment and ultrasound were performed.The study leg abi was 0.63 and the rutherford classification was one.The portion within the stented segment was occluded.The proximal and distal portions of the stented segment were 50-99% stenosed.Core lab evaluation of the ultrasound revealed that the stent was occluded.

• 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: 6601364
• MDR Text Key: 76309925
• Report Number: 3001845648-2017-00203
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 00827002350625
• UDI-Public: (01)00827002350625(17)150329(10)C969444
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 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 Catalogue Number: ZIV6-35-125-5.0-40-PTX-CI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/31/2017
• Date Device Manufactured: 02/10/2014
• 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: 76 YR
• Patient Weight: 73