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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s001.This investigation captures the restenosis of a ziv6-35-125-7.0-120-ptx (lot# c781662) stent was placed in the lower part of the left sfa of a male patient (b)(6) 2012.On (b)(6) 2017 restenosis in the area distal to the stented lesion was confirmed.Worsened intermittent claudication was observed on the patient.Cut balloon was conducted against the restenosis on the same day and the condition of the patient recovered.The ziv6-35-125-7.0-120-ptx stent of lot number c781662 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator that there are no images available for review.It is known the patient had the following pre-existing condition: carotid artery disease, hypertension, diabetes (type2), hypercholesterolemia 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 for review, a definitive root cause of this event cannot be determined.It may be noted that the packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.In addition worsened claudication is also listed as a potential adverse event associated with the placement in this device as per the packaging insert a query is currently pending with the clinical reviewer to determine if the restenosis reported is related to the zilver ptx stent implanted.The investigation will be updated when a response is received.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 occurred previously with the lot number c781662.However, based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c781662.Therefore no action required.(ref.Att.Re pr 203165 - complaints review) an intervention using the cutting balloon was conducted against the restenosis on the same day and the condition of the patient recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.H3 other text : 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: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 pma/510(k) #p100022/s001 this investigation captures the restenosis of a ziv6-35-125-7.0-120-ptx (lot# c781662) stent was placed in the lower part of the left sfa of a male patient 25 sep 2012.On 15 sep 2017 restenosis in the area distal to the stented lesion was confirmed.Worsened intermittent claudication was observed on the patient.Cut balloon was conducted against the restenosis on the same day and the condition of the patient recovered.The ziv6-35-125-7.0-120-ptx stent of lot number c781662 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator that there are no images available for review.It is known the patient had the following pre-existing condition: carotid artery disease, hypertension, diabetes (type2), hypercholesterolemia 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 for review, a definitive root cause of this event cannot be determined.It may be noted that the packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.In addition worsened claudication is also listed as a potential adverse event associated with the placement in this device as per the packaging insert a query is currently pending with the clinical reviewer to determine if the restenosis reported is related to the zilver ptx stent implanted.The investigation will be updated when a response is received.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 occurred previously with the lot number c781662.However, based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c781662.Therefore no action required.(ref.Att.Re pr 203165 - complaints review) an intervention using the cutting balloon was conducted against the restenosis on the same day and the condition of the patient recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012.A ziv6-35-125-7.0-120-ptx(lot# c781662) stent was placed in the lower part of the left sfa of a male patient.On (b)(6) 2017.Restenosis in the area distal to the stented lesion was confirmed.Worsened intermittent claudication was observed on the patient.Cut balloon was conducted against the restenosis on the same day and the condition of the patient recovered.

• 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: 6999315
• MDR Text Key: 90976253
• Report Number: 3001845648-2017-00505
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513539
• UDI-Public: (01)10827002513539(17)140514(10)C781662
• 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
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7.0-120-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: 11/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/05/2017
• Date Device Manufactured: 06/28/2012
• 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: 84 YR