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

Catalog Number ZISV6-35-125-6.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s014.The zisv6-35-125-6.0-120-ptx device of lot number c1250553 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.There are three other stents and complaint files linked to this occurrence.Refer to reports# 3001845648-2017-00297, 3001845648-2017-00299 and 3001845648-2017-00300 for the investigation details of the other devices.From customer testimony, it is known the patient was a current smoker with a history of hypertension.The device was used in a study, and the lesion had a rutherford classification of two.The patient was administered aspirin and clopidogrel pre-procedurally.The customer was contacted to provide images of the implanted device.The investigation will be updated once the images have been provided and reviewed.There is no evidence to suggest this event did not occur.Therefore, the customer 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 the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.From the information provided, it is known that the patient had risk factors for restenosis, including smoking and prior history of hypertension.The patient exhibited a re-emergence of claudication, which could suggest a progression of the peripheral arterial disease in the proximal superficial femoral artery (sfa).However, as images of the device have not yet been provided, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.As per the product instruction for use, restenosis of the stented artery is listed under potential adverse effects.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 this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1250553.From customer testimony, treatment for this event included further stenting.No other adverse effects were reported for the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(6), re-intervention due to product-related occlusion.On (b)(6) 2016 during the index procedure the patient received four zilver© ptx© stents.The study lesion was in the right proximal sfa, 300 mm in length.The lesion status was de novo with none calcification, no thrombus, a patent inflow tract, and one patent runoff vessel.The proximal reference vessel diameter (rvd) was 6.0 mm, the distal rvd was 5.0 mm with 100% diameter stenosis in study lesion.The lesion was pre-dilated using a bare-balloon angioplasty.Following pre-stent dilation there was 70% stenosis left in study lesion.There were no difficulties during the procedure and 0% diameter stenosis left in study lesion post-procedure.The patient was discharged on (b)(6) 2016.On (b)(6) 2017 (195 days post-procedure), the six months follow-up clinical assessment was performed.The study leg rutherford classification was two and the study lesion status was occluded.Prior to the follow-up visit, the patient was taking aspirin and clopidogrel.On (b)(6) 2017 (202 days post-procedure), a re-intervention was performed.Event location was the right femoral artery (study lesion).The re-intervention was due to occlusion which was diagnosed with persistent claudication and angiography.The angiography showed 100% diameter stenosis.The patient had a stent placed endovascularly.The event was thought to be ¿definitely related to study device¿ and ¿not related to study procedure¿.No pre-existing condition caused or contributed to this event.In a comment field the site has stated ¿right and left femorale.¿ a query has been issued to clarify that.Please note 3 additional related reports were submitted for the event.Reference related reports: 3001845648-2017-00297, 3001845648-2017-00299 and 3001845648-2017-00300.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s014.This follow up mdr is being submitted due to the receipt and review of images relating to this event.The zisv6-35-125-6.0-120-ptx device of lot number c1250553 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.There are three other stents and complaint files linked to this occurrence.Refer to reports# 3001845648-2017-00297, 3001845648-2017-00299 and 3001845648-2017-00300 for the investigation details of the other devices.From customer testimony, it is known the patient was a current smoker with a history of hypertension.The device was used in a study, and the lesion had a rutherford classification of two.The patient was administered aspirin and clopidogrel pre-procedurally.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: pre-implantation angiography two days prior to implantation, implantation angiography of the right and study stent leg, implantation angiography of the left and non-study stent leg, and follow up angiography seven months post implantation is provided along with the complaint report.The (b)(6) 2016 diagnostic aortogram with runoff was performed from a brachial or radial approach.It demonstrated right superficial femoral artery (sfa) occlusion except for the ostium with extension into the right popliteal artery (pa) just superior to the patella.Left sfa occlusion reconstituted at the adductor canal on the left.Runoff was two vessel on the right and three on the left.Inflow was normal except for a mild right common femoral artery (cfa) stenosis from an ulcerated plaque.Two days later on (b)(6) 2016, from a left cfa approach, the right sfa and pa occlusion was recanalized, angioplastied, and then stented.Lumen reentry of the subintimal recanalization was achieved just inferior to the occlusion just superior to the mid patella level.The 5x120mm stent was implanted first and most distally to a length of 115mm.The 6x120mm stent was implanted next, overlapping the superior 5x120mm stent by 4mm.The 6x100mm was implanted next, overlapping the superior 6x120mm stent by 5mm.Finally, the 6x60mm stent was implanted, overlapping the 6x100mm stent by 20mm.Total stented length was 36.5cm, spanning from the above knee pa at the level of the superior patella to the right sfa ostium.The entire length was post stent angioplastied to design stent diameter.Complete stent expansion was achieved although 25% residual stenosis at the adductor canal was caused by eccentric, partially calcified plaque.Twelve days later on (b)(6) 2016, recanalization and stenting of the left sfa occlusion with stents consistent with zilver stents was performed.Follow up angiography on (b)(6) 2017 was performed from a radial or brachial approach.It demonstrated right stent occlusion except for the distal centimeter of the distal most stent.On the left sfa severe in-stent stenosis involving the proximal and middle of the three left sfa stents had developed.Runoff remained two vessel on the right and three on the left however, the caliber of the runoff vessels was diffusely diminished reflecting the upstream pressure drop.Angiography from the subsequent secondary intervention was not provided.Impression : right study stent occlusion and left non-study stent severe stenosis, seven months post implantation is confirmed.Because the shorter left stented length developed severe in-stent stenosis, the long right stented length was less important than the systemic cause of continued tobacco abuse.Although the right stent extension into the pa increased the risk of acute thrombosis from kinking, neointimal hyperplasia likely caused the occlusion because of absent early symptomatology and the reported difficult wire recanalization.Significant findings relative to the anatomy were not observed.Significant findings relative to the disease state were observed.Continued tobacco abuse was reported significant findings relative to the use of the device were observed.The right stented length was very long and extended well into the pa.Significant findings relative to the design or performance of the device were observed.The right stents occluded, likely from neointimal hyperplasia.The left stents developed severe in-stent stenosis from neointimal hyperplasia.Cause of adverse events was not observed.Complaint is confirmed as the failure was verified in the image(s).Occlusion of the implanted stents was observed in the image review.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 the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.From the information provided, it is known that the patient had risk factors for restenosis, including smoking and prior history of hypertension.From the image review, the most likely root causes were cell ingrowth (neointimal hyperplasia) and ongoing tobacco use.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.As per the product instruction for use, restenosis of the stented artery is listed under potential adverse effects.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 this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1250553.From customer testimony, treatment for this event included further stenting.No other adverse effects were reported for the patient.Complaints of this nature will continue to be monitored for 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: (b)(4), pt.(b)(6), re-intervention due to product-related occlusion.On (b)(6) 2016 during the index procedure the patient received four zilver© ptx© stents.The study lesion was in the right proximal sfa, 300 mm in length.The lesion status was de novo with none calcification, no thrombus, a patent inflow tract, and one patent runoff vessel.The proximal reference vessel diameter (rvd) was 6.0 mm, the distal rvd was 5.0 mm with 100% diameter stenosis in study lesion.The lesion was pre-dilated using a bare-balloon angioplasty.Following pre-stent dilation there was 70% stenosis left in study lesion.There were no difficulties during the procedure and 0% diameter stenosis left in study lesion post-procedure.The patient was discharged on (b)(6) 2016.On (b)(6) 2017 (195 days post-procedure), the six months follow-up clinical assessment was performed.The study leg rutherford classification was two and the study lesion status was occluded.Prior to the follow-up visit, the patient was taking aspirin and clopidogrel.On (b)(6) 2017 (202 days post-procedure), a re-intervention was performed.Event location was the right femoral artery (study lesion).The re-intervention was due to occlusion which was diagnosed with persistent claudication and angiography.The angiography showed 100% diameter stenosis.The patient had a stent placed endovascularly.The event was thought to be ¿definitely related to study device¿ and ¿not related to study procedure¿.No pre-existing condition caused or contributed to this event.In a comment field the site has stated ¿right and left femorale.¿ a query has been issued to clarify that.Please note 3 additional related reports were submitted for the event.Reference related reports: 3001845648-2017-00297, 3001845648-2017-00299 and 3001845648-2017-00300.

• 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: 6739784
• MDR Text Key: 80891682
• Report Number: 3001845648-2017-00298
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352855
• UDI-Public: (01)10827002352855(17)180428(10)C1250553
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2017
• Date Device Manufactured: 07/07/2016
• 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: 57 YR
• Patient Weight: 69