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 Stenosis (2263)

Event Date 01/28/2015

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-7.0-120-ptx stent of lot number c777751 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.According to complaint information provided, the patient had pre-existing conditions including coronary artery disease, hypertension, hypercholesterolemia, diabetes (type ii) and was a previous smoker.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; however a definitive cause of this event cannot be determined.Due to lack of imaging no other comments can be made.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It may be noted that restenosis of the stented artery is a known potential adverse event 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 recovered.No other adverse events were reported for the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Right leg> (b)(6) 2012: ziv6-35-125-6.0-120-ptx / (b)(4) + ziv6-35-125-7.0-120-ptx / c777751 x 1 were placed from the right sfa to pop.Artery above the knee.(b)(6) 2015: restenosis at +/- 5mm of the ptx stent(s) was confirmed.(the rpn or lot number of the re-stenosed device(s) cannot be determined).(b)(6) 2015: pta was performed.(b)(6) 2015: the patient recovered. (b)(6) 2012: ziv6-35-125-6.0-120-ptx / c778924 x 1 + ziv6-35-125-6.0-120-ptx / c778569 1 + ziv6-35-125-6.0-60-ptx / c777742 were placed in the left sfa.(b)(6) 2015: restenosis at +/- 5mm of the ptx stent(s) was confirmed.(the rpn or lot number of the re-stenosed device(s) cannot be determined).(b)(6) 2015: pta was performed.(b)(6) 2015: the patient recovered.As the stenosed device cannot be determined on either leg a separate report has been submitted for each suspect device.Reference also report # 3001845648-2016-00002, 3001845648-2016-00003, 3001845648-2016-00005, 3001845648-2016-00006, 3001845648-2016-00007.

Manufacturer Narrative

This follow up report is being submitted to cancel the initial report submitted.The initial information received stated the patient received additional treatment on both the (b)(6) 2015 on his right leg.A separate report was submitted for each event date.Additional information received confirmed the date of event to be (b)(6) 2015 only.This patient did not receive additional treatment on two separate dates for this leg.Therefore this pr is cancelled as no event occurred for this patient on the (b)(6) 2015 on his right leg.

Event Description

This follow up report is being submitted to cancel the initial report submitted.The initial information received stated the patient received additional treatment on both the (b)(6) 2015 on his right leg.A separate report was submitted for each event date.Additional information received confirmed the date of event to be (b)(6) 2015 only.This patient did not receive additional treatment on two separate dates for this leg.Therefore this pr is cancelled as no event occurred for this patient on the (b)(6) 2015 on his right leg.

• 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: 5350193
• MDR Text Key: 35246647
• Report Number: 3001845648-2016-00004
• 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
• Report Date: 01/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• 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: 01/28/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2012
• 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 Age: 66 YR