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

Catalog Number ZIV6-35-125-6.0-40-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exemption number: e2016031.The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.

Event Description

(b)(6), occlusion possibly related to device.On (b)(6) 2016 during the index procedure the patient received two zilver¿ ptx¿ stents.The study lesion was in the right distal sfa and popliteal artery.The lesion status was de novo and there were no calcification or thrombus observed pre-procedure.The inflow tract was patient and there were three runoff vessels.The lesion length was 60 mm and the proximal and distal rvd were both 5 mm.The percentage diameter stenosis in study lesion was 100 %.A bare balloon angioplasty was performed prior to index procedure.Following pre-stent treatment the percentage diameter stenosis was 30 %.The post-procedure imaging showed 0 % diameter stenosis left in the study lesion.On (b)(6) 2017 (180 days post-procedure), the follow-up clinical assessment revealed a study leg rutherford classification of three.The study lesion status was patent but the maximum peak systolic velocity (psv) proximal to stented segment was 230 cm/sec and the percentage diameter stenosis was 70 %.The patient was still taking aspirin.An angioplasty was performed endovascularly in the study vessel due to persistent claudication and imaging evidence.The event was occlusion in the study lesion (including up to 5 mm proximal and/or distal to study lesion) and it was thought to be probably related to device and possibly related to procedure.A pre-existing condition of multi-stage atheromatous lesions was also noted as contributor to the event.As there were two suspect zilver ptx devices involved reference also related report# 3001845648-2017-00304.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.(b)(6).Importer site establishment registration number: 3005580113.This follow up report is being submitted due to the completion of the investigation into this event and an update to the conclusion of this investigation.It is known that the following two devices were implanted into the patient: zisv6-35-125-6.0-100-ptx / c1261618 / 1, ziv6-35-125-6.0-40-ptx / c1127577 / 1 as there were two suspect zilver ptx devices involved reference also related report# 3001845648-2017-00304.This report investigates ziv6-35-125-6.0-40-ptx / c1127577 / 1.The device was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It is known the patient had the following pre-existing conditions: history of coronary artery disease, hypertension, hypercholesterolemia and is a current smoker.Study leg rutherford classification was three and the patient was taking aspirin pre-procedurally.There is currently a query pending with the originator to determine if there is imaging available for evaluation and to confirm if any of the device is returning for evaluation.The investigation will be updated following the receipt of this information.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 as per the instructions for use, 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 not occurred previously with the lot number c1127577.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1127577.An angioplasty was performed endovascularly in the study vessel.No other adverse events were reported as a result of this event.The patient remains in the study.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

This follow up report is being submitted due to the completion of the investigation into this event and an update to the conclusion of this investigation.Initial report details: 12-011, pt.1460085, occlusion possibly related to device.On (b)(6) 2016 during the index procedure the patient received two zilver¿ ptx¿ stents.The study lesion was in the right distal sfa and popliteal artery.The lesion status was de novo and there were no calcification or thrombus observed pre-procedure.The inflow tract was patient and there were three runoff vessels.The lesion length was 60 mm and the proximal and distal rvd were both 5 mm.The percentage diameter stenosis in study lesion was 100 %.A bare balloon angioplasty was performed prior to index procedure.Following pre-stent treatment the percentage diameter stenosis was 30 %.The post-procedure imaging showed 0 % diameter stenosis left in the study lesion.On (b)(6) 2017 (180 days post-procedure), the follow-up clinical assessment revealed a study leg rutherford classification of three.The study lesion status was patent but the maximum peak systolic velocity (psv) proximal to stented segment was 230 cm/sec and the percentage diameter stenosis was 70 %.The patient was still taking aspirin.An angioplasty was performed endovascularly in the study vessel due to persistent claudication and imaging evidence.The event was occlusion in the study lesion (including up to 5 mm proximal and/or distal to study lesion) and it was thought to be probably related to device and possibly related to procedure.A pre-existing condition of multi-stage atheromatous lesions was also noted as contributor to the event.As there were two suspect zilver ptx devices involved reference also related report# 3001845648-2017-00304.

• 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: 6749779
• MDR Text Key: 81235851
• Report Number: 3001845648-2017-00308
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513416
• UDI-Public: (01)10827002513416(17)170521(10)C1127577
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/28/2017

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: ZIV6-35-125-6.0-40-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: 07/28/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 08/22/2017
• Date Device Manufactured: 07/03/2015
• 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: 52 YR
• Patient Weight: 46