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

Catalog Number ZIV6-35-125-7.0-100-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

(b)(4).(b)(6).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This complaint addresses stent restenosis on the treated lesion on 2015 leading to the first additional stent (zilver ptx 7x80mm).In 2015, the patient who had critical limb ischemia on right lower limb had been treated with zilver ptx 7x100mm and smart control (cordis)7x40mm.In 2016, to treat in stent restenosis on the treated lesion on 2015, zilver ptx 7x80mm was used.On (b)(6) 2017, stent occlusion was occurred, so viabahn (gore) was inserted into the lesion.The patient has been discharged.On (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.The 4fr sheath, 4fr multipurpose catheter were inserted, then, 0.035indh wire guide (radifocus) was inserted to passed through the entire occluded lesion and performed peripheral 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 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: 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 artificial 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.On (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

(b)(4).Exemption number: e2016031.(b)(4).This report is being cancelled as it has been confirmed with the physician that the event (in stent restenosis) involved a non-cook device.As a result the event does not meet the criteria of an fda report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.

Event Description

This report is being submitted as a cancellation report following confirmation that a cook device was not involved.This complaint addresses stent restenosis on the treated lesion on 2015 leading to the first additional stent (zilver ptx 7x80mm).[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.[(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 peripheral 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 attempts, 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 artificial 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 (b)(4)]: 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 occlusion and zilver.

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7893439
• MDR Text Key: 120862540
• Report Number: 3001845648-2018-00436
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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: ZIV6-35-125-7.0-100-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/19/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR