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

Catalog Number ZISV6-35-125-7.0-80-PTX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This complaint addresses the 2017 stent occlusion and intervention.It has not been possible to confirm which of the 3 stents implanted were involved, so 2 files have been created to address both cook stent in place at the time, adopting a cautious approach.This file will address zisv6-35-125-7.0-80-ptx.Related file (b)(4) will address ziv6-35-125-7.0-100-ptx.[2015].The patient who had critical limb ischemia on right lower limb had been treated with zilver ptx 7x100mm and smart control (cordis) 7x40mm.[2016].To treat in stent restenosis on the treated lesion on 2015, zilver ptx 7x80mm was used.[(b)(6) 2017].Stent occlusion was occurred, so viabahn(gore) was inserted into the lesion.The patient has been discharged.[(b)(6) 2018].The patient came to the hospital again due to acute occlusion, and thrombectomy was completed however it was difficult.Therapeutic strategy and planned operative procedure: it was planned thrombectomy with wire-fogarty catheter by femoral artery.Operation procedure details: under general anesthesia, after taping right fa, right fa was cut down as cross direction.4fr sheath, 4fr multipurpose catheter were inserted, then, 0.035indh wire guide (radifocus) was inserted to passed through the entire occluded lesion and performed pheripheral angiography.Thrombectomy was started with "wire-forgarty balloon" technique, however, small amount of the thrombosis removed.It was confirmed that the lesion almost occluded by angiography.The physician increased the dilation pressure of the balloon more (by hand), after several time attention, the thrombosis started to be removed gradually.At the time of slight amount of thrombosis has been removed at proximal and distal lesion, it became possible to remove the center thrombosis.At the end, it was confirmed that the organic stenosis at proximal side of native vessel, so the bare stent was placed and complete the procedure.Right after surgery, chdf was started against infection and mnms , however, on day 25, the patient deceased by vf due to progression of infection and sphacelus.The point of self-searching: viavahn was used as bail-out after two times of stent occlusion.However, the patient visited to another hospital due to maintenance dialysis.Therefore, it made to be late to identify of indication of occlusion.This cli case with the patient who had severe coronary artery disease and maintenance dialysis, so it made to be late to identify of indication of infection.For thrombectomy for viavan, it was considered there was trick such as it separate small section when taking thrombosis, and also it was needed to prepare the fogarty catheter for artifical artery.Since removed thrombosis was organized thrombosis with infection, therefore sepsis was also one of the cause of early occlusion.It was thought that the cause of vf was due to multifactor such as chf, mi, systemic infection.[(b)(6) 2018]: physician's comment.I have an experience that the severe thrombosis occurred after placement of the viabahn.I think an acute occlusion was related with viabahn, and there was no relation between occlusion and zilver.

Event Description

This complaint addresses the 2017 stent occlusion and intervention.It has not been possible to confirm which of the 3 stents implanted were involved so 2 files have been created to address both cook stent in place at the time, adopting a cautious approach.This file will address zisv6-35-125-7.0-80-ptx.Related file 239158 will address ziv6-35-125-7.0-100-ptx.[2015]: the patient who had critical limb ischemia on right lower limb had been treated with zilver ptx 7x100mm and smart control (cordis)7x40mm.[2016]: to treat in stent restenosis on the treated lesion on 2015, zilver ptx 7x80mm was used.[(b)(6) 2017] : stent occlusion was occurred, so viabahn(gore) was inserted into the lesion.The patient has been discharged.[(b)(6) 2018]: the patient came to the hospital again due to acute occlusion, and thrombectomy was completed however it was difficult.Therapeutic strategy and planned operative procedure.It was planned thrombectomy with wire-fogarty catheter by femoral artery.Operation procedure details.Under general anesthesia, after taping right fa, right fa was cut down as cross direction.4fr sheath, 4fr multipurpose catheter were inserted, then, 0.035indh wire guide (radifocus) was inserted to passed through the entire occluded lesion and performed pheripheral angiography.Thrombectomy was started with "wire-forgarty balloon" thechnique, however, small amount of the thrombosis removed.It was confirmed that the lesion almost occluded by angiography.The physician increased the dilation pressure of the balloon more (by hand), after several time attemption, the thrombosis started to be removed gradually.At the time of slight amount of thrombosis has been removed at proximal and distal lesion, it became possible to remove the center thrombosis.At the end, it was confirmed that the organic stenosis at proximal side of native vessel, so the bare stent was placed and complete the procedure.Right after surgery, chdf was started against infection and mnms , however, on day 25, the patient deceased by vf due to progression of infection and sphacelus.The point of self-searching.1.Viavahn was used as bail-out after two times of stent occlusion.However, the patient visited to another hospital due to maintenance dialysis.Therefore, it made to be late to identify of indication of occlusion.2.This cli case with the patient who had severe coronary artery disease and maintenance dialysis, so it made to be late to identify of indication of infection.3.For thrombectomy for viavan, it was considered there was trick such as it separate small section when taking thrombosis, and also it was needed to prepare the fogarty catheter for artifical artery.4.Since removed thrombosis was organized thrombosis with infection, therefore sepsis was also one of the cause of early occlusion.5.It was thought that the cause of vf was due to multifactor such as chf, mi, systemic infection.[(b)(6) 2018 (b)(6) ]: physician's comment: -i have an experience that the severe thrombosis occurred after placement of the viabahn.-it think an acute occlusion was related with viabahn, and there was no relation between occlution and zilver.

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This complaint addresses the 2017 stent occlusion and intervention.It has not been possible to confirm which of the 3 stents implanted were involved so 2 files have been created to address both cook stent in place at the time, adopting a cautious approach.This file will address zisv6-35-125-7.0-80-ptx.Related file 239158 will address ziv6-35-125-7.0-100-ptx.[2015]: the patient who had critical limb ischemia on right lower limb had been treated with zilver ptx 7x100mm and smart control (cordis)7x40mm.[2016]: to treat in stent restenosis on the treated lesion on 2015, zilver ptx 7x80mm was used.[(b)(6) 2017] : stent occlusion was occurred, so viabahn(gore) was inserted into the lesion.The patient has been discharged.[(b)(6) 2018]: the patient came to the hospital again due to acute occlusion, and thrombectomy was completed however it was difficult.Therapeutic strategy and planned operative procedure.It was planned thrombectomy with wire-fogarty catheter by femoral artery.Operation procedure details.Under general anesthesia, after taping right fa, right fa was cut down as cross direction.4fr sheath, 4fr multipurpose catheter were inserted, then, 0.035indh wire guide (radifocus) was inserted to passed through the entire occluded lesion and performed pheripheral angiography.Thrombectomy was started with "wire-forgarty balloon" thechnique, however, small amount of the thrombosis removed.It was confirmed that the lesion almost occluded by angiography.The physician increased the dilation pressure of the balloon more (by hand), after several time attemption, the thrombosis started to be removed gradually.At the time of slight amount of thrombosis has been removed at proximal and distal lesion, it became possible to remove the center thrombosis.At the end, it was confirmed that the organic stenosis at proximal side of native vessel, so the bare stent was placed and complete the procedure.Right after surgery, chdf was started against infection and mnms , however, on day 25, the patient deceased by vf due to progression of infection and sphacelus.The point of self-searching.1.Viavahn was used as bail-out after two times of stent occlusion.However, the patient visited to another hospital due to maintenance dialysis.Therefore, it made to be late to identify of indication of occlusion.2.This cli case with the patient who had severe coronary artery disease and maintenance dialysis, so it made to be late to identify of indication of infection.3.For thrombectomy for viavan, it was considered there was trick such as it separate small section when taking thrombosis, and also it was needed to prepare the fogarty catheter for artifical artery.4.Since removed thrombosis was organized thrombosis with infection, therefore sepsis was also one of the cause of early occlusion.5.It was thought that the cause of vf was due to multifactor such as chf, mi, systemic infection.[(b)(6) 2018 (b)(6) ]: physician's comment: -i have an experience that the severe thrombosis occurred after placement of the viabahn.-it think an acute occlusion was related with viabahn, and there was no relation between occlution and zilver.

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.It should be noted that this investigation was conducted to capture the event of stent occlusion that occurred in (b)(6) 2017.It is not known which stent was involved in this incident but it should be noted that there were two zilver stents implanted in the patient prior to this occurrence.This file has been opened as it is a possibility that the stent that occluded in 2017 was one of the zilver stents implanted in the patient at that time.The following statement was made by the physician ¿the possibility that the zilver is related to these events is zero.There are two files related to this complaint.Please refer to (b)(4) for details of the second investigation.The second file was opened to cover the second zilver stent that could possibly have been involved in the stent occlusion event in 2017.Device evaluation: the zisv6-35-125-7.0-80-ptx device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From the information provided, in 2015 the patient was treated for critical limb ischemia with a 7x100mm zilver ptx stent and a smart control (cordis) 7x40mm stent.In 2016 a 7x80mm zilver ptx stent was placed to treat an in-stent restenosis of the smart control stent (ref.Att.¿(b)(4) rep confirms stent involved in in-stent restenosis¿).The patient presented with a stent occlusion in 2017 resulting in the placement of a viabahn stent.It is unknown if either of the zilver stents previously placed were involved in this event.In 2018 the patient presented with an acute occlusion for which a thrombectomy was performed.Right after surgery, chdf (capillary hydrodynamic fractionation (haemofiltration)) was started against infection and mnms, however, on day 25, the patient deceased by vf (ventricular fibrillation) due to progression of infection and sphacelus.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Root cause: the most likely root cause for this complaint is thrombosis as a result of the patient¿s pre-existing conditions.It is known that the patient was undergoing maintenance dialysis and suffered from diabetes (insulin user), brain-stem infarction, cerebellar infarction, chronic heart failure (post pci).However, as the device was unavailable for evaluation, as images of the procedure were not available and as circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the japanese packaging insert.However, it may be noted that the packaging insert lists "restenosis or occlusion of the stented artery" as a known potential adverse event.It may be noted that the instructions for use also lists "restenosis of the stented artery" as a known potential adverse event.Document review: as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.According to the initial reporter, the patient deceased by vf due to progression of infection and sphacelus.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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
• MDR Report Key: 7983980
• MDR Text Key: 124332967
• Report Number: 3001845648-2018-00489
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2018

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: ZISV6-35-125-7.0-80-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 08/30/2018; 08/30/2018
• Supplement Dates FDA Received: 11/15/2018; 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR