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

Catalog Number ZIV6-35-125-6.0-60-PTX

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 10/29/2014

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-6.0-60-ptx stent of lot number cf766313 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.It was confirmed that images would not be available to support the complaint investigation.Available information stated that the patient had pre-existing conditions including hypertension, hypercholesterolemia, diabetes and was a previous smoker.According to complaint information provided, worsen claudication was observed on the patient.It can be noted that worsen claudication indicates progression of peripheral artery disease and can also be associated with the restenosis process.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 cause of this event cannot be determined.Due to lack of imaging no other comments can be made.As no imaging was available to support the complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that worsened claudication and restenosis of the stented artery are known potential adverse events associated with 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.According to information provided pta was performed and the patient had a favourable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012: three zilver ptx stents (ziv6-35-125-6.0-120-ptx / cf766268 x 2 + ziv6-35-125-6.0-60-ptx / cf766313 x 1) were placed in the right sfa of the patient.On (b)(6) 2014: restenosis at +/- 5mm of the ptx stent(s) was confirmed.(the rpn or lot number of the re-stenosed device(s) cannot be determined.) "worsen claudication", "worsen rutherford" and "rest pain" were observed.On (b)(6) 2014: pta was performed.The patient had a favorable outcome.Note three zilver ptx devices are suspected to be involved in this event.Reference also related reports 3001845648-2015-00242 and 3001845648-2015-00241.

Manufacturer Narrative

Images relating to this event have been received.Image review is currently pending with an external independent reviewer.A follow up report will be submitted with the image review conclusions upon receipt.

Event Description

Images relating to this event have been received.Image review is currently pending with an external independent reviewer.A follow up report will be submitted with the image review conclusions upon receipt.

Manufacturer Narrative

The ziv6-35-125-6.0-60-ptx stent of lot number cf766313 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation.These were reviewed and the following comments were provided by the independent reviewer: ¿findings: the occlusion was recanalized through a combination of retrograde popliteal and antegrade approaches.The lumen was successfully restored after angioplasty however significant moderate diffuse stenosis remained.The stents were then implanted from distal to proximal with the 60mm stent most proximal.The stented length was 27.8cm; after stent angioplasty, less than 20% stenoses were present in the mid sfa stent just proximal its overlap with the distal stent and in the distal stent at the adductor canal; the unstented sfa improved to 3-4mm in diameter except at the stent end.There an enface stenoses narrowed the lumen even further.Because only one projection was provided the exact severity was not quantifiable; secondary intervention angiography demonstrated short segment (5-15mm long) 50-75% stenoses throughout the proximal and mid stents except for a greater than 75% stenosis in the superior proximal stent.The superior half of the distal stent was diffusely narrowed 50% while the distal half was narrowed greater than 75%.This stenosis was nearly occlusive and continued 5mm distal the stent into the more distal unstented sfa.Atherosclerotic disease in the unstented sfa and above knee pa artery also had progressed so that short lengths of 75% stenosis superimposed on diffuse 50% stenosis.The poor distal runoff was worse with a new long segment near occlusive stenosis added to the pre-existing occlusions; the in-stent and distal sfa and above knee pa stenosis improved to less than 50% with the majority less than 25% residual stenosis.No inflow limitation was present although the extensive severely calcific atherosclerotic disease with popliteal occlusion was also demonstrated on the left.Impression: the stents developed extensive neointimal hyperplasia with near occlusive stenosis in the distal stent extending into the distal unstented sfa.The stenoses were relieved by angioplasty; stent patency faced numerous challenges.The most significant was extremely poor runoff with significant residual stenosis in the unstented sfa immediately distal the stent added to the extensive pa and calf trifurcation occlusive disease.Other challenges included long stent length, severe overall heavily calcified atherosclerotic burden, hyperlipidemia, and diabetes; significant findings relative to the patient¿s anatomy were observed.The runoff was extremely poor with no continuous single vessel runoff to the foot; significant findings relative to the disease state were observed.The disease was severe and heavily calcified; significant findings relative to the use of the device were observed.The stented length was very long and stopped short of a significant stenosis in the distal sfa; significant findings relative to the design or performance of the device were observed.The stents developed significant neointimal hyperplasia; restenosis is confirmed.¿ the customer complaint can be confirmed as the imaging review confirmed restenosis.According to the imaging review, the stents developed neointimal hyperplasia with near occlusive stenosis in the distal stent extending into the distal unstented sfa.Significant findings relative to patient anatomy and disease state were observed.The most significant was extremely poor runoff with significant residual stenosis in the unstented sfa immediately distal the stent added to the extensive pa and calf trifurcation occlusive disease.Other challenges included long stent length, severe overall heavily calcified atherosclerotic burden, hyperlipidemia, and diabetes.According to complaint information provided, worsen claudication was also observed on the patient.It can be noted that worsen claudication indicates progression of peripheral artery disease and can also be associated with the restenosis process.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 the 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.Based on the above, the most likely cause of restenosis was the patient¿s condition; however a definitive root cause of this event cannot be determined.It may be noted that worsened claudication and restenosis of the stented artery are known potential adverse events associated with 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.According to information provided pta was performed and the patient had a favourable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the receipt and review of images relating to this event.Initial event description submitted as follows: on (b)(6) 2012: three zilver ptx stents (ziv6-35-125-6.0-120-ptx / cf766268 x 2 + ziv6-35-125-6.0-60-ptx / cf766313 x 1) were placed in the right sfa of the patient.On (b)(6) 2014: restenosis at +/- 5mm of the ptx stent(s) was confirmed.(the rpn or lot number of the re-stenosed device(s) cannot be determined.) "worsen claudication", "worsen rutherford" and "rest pain" were observed.On (b)(6) 2014: pta was performed.The patient had a favourable outcome.Note three zilver ptx devices are suspected to be involved in this event.Reference also related reports 3001845648-2015-00242 and 3001845648-2015-00241.

• 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: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5229509
• MDR Text Key: 31447545
• Report Number: 3001845648-2015-00243
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-60-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR