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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s001.It is known that the following 3 devices were implanted in the patient: ziv6-35-125-6.0-120-ptx / c778569 / 1, ziv6-35-125-6.0-120-ptx / c778569 / 1, ziv6-35-125-6.0-120-ptx / c778569 / 1.Please note 2 additional related reports were submitted for the event.Reference related reports: 3001845648-2017-00362 and 3001845648-2017-00364.The devices were implanted in the patient and are therefore unavailable for evaluation.With the information a document based investigation was carried out.It is known that the patient had the following pre-existing conditions: coronary artery disease, hypertension and was previously a smoker.A query was sent to the originator to determine if there were images available for review.The investigation will be updated when a response is received.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 at the time of investigation, a definitive root cause of this event cannot be determined at this time.As per the packaging insert 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.Upon review of complaints, this failure mode has occurred previously with the lot number c778569.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 c778569.Stent placement and thrombectomy were conducted against the restenosis and the patient's condition was improved.No other adverse events were reported as a result of this occurrence.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012: 3 ptx stents below were placed in the right sfa of the patient.Ziv6-35-125-6.0-120-ptx lot#c778569, ziv6-35-125-6.0-120-ptx lot#c778569, ziv6-35-125-6.0-120-ptx lot#c778569.On (b)(6) 2017: 100% restenosis was confirmed in the stented lesion, distal to the lesion and proximal to the lesion.Intermittent claudication was observed on the patient.Stent placement(detail:unknown, but not zilver stent) and thrombectomy were conducted against the restenosis and the patient's condition was improved please note 2 additional related reports were submitted for the event.Reference related reports: 3001845648-2017-00362 and 3001845648-2017-00364.

• 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: 6819836
• MDR Text Key: 83612625
• Report Number: 3001845648-2017-00363
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140515(10)C778569
• 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: Other
• Type of Report: Initial
• Report Date: 07/28/2017

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: ZIV6-35-125-6.0-120-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: 08/25/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/25/2017
• Date Device Manufactured: 06/20/2012
• 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: 79 YR