MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problem Unspecified Infection (1930)

Event Date 08/08/2016

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.During the median follow up of 11.1 (range, 1-26) months, it is known that of the 46 patients 6 limbs experienced loss of stent patency, 4 underwent target lesion revascularization, 2 required open bypass, 2 underwent thrombolysis and no patients required major amputation.For the purpose of regulatory reporting 8 separate complaint files were created to address each issue.Related reports: 3001845648-2016-00345, 3001845648-2016-00346, 3001845648-2016-00347, 3001845648-2016-00348, 3001845648-2016-00349 & 3001845648-2016-00350.This report addresses one case of graft infection which required hospitalization with intravenous antibiotics and eventual graft explant and open bypass.The rpn and lot numbers of the stents involved in this study are unknown.Particular pre-existing condition of the patient involved are unknown, however from information provided it is known that the study population had the following baseline characteristics; diabetes, coronary disease, hypertension, atrial fibrillation, hyperlipidemia, chronic renal insufficiency, statin use, between the ages of 40 ¿ 92 and were past or present smokers.In addition limb and lesion characteristics included; chronic total occlusion, long lesion lengths, claudication, critical limb ischemia and prior revascularization of the lesion.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It is very unlikely that the reported occurrence could have occurred due to zilver ptx malfunction.However, due to limited information and as the conditions of use cannot be replicated, a definitive root cause cannot be determined.It may be noted that the following information are known potential adverse events associated with the device: "potential adverse events that may occur include, but are not limited to, the following: - allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium.- allergic reaction to nitinol.- hypersensitivity reactions.- infection.Potential adverse events, not described in the above source, may be unique to the paclitaxel drug coating: - allergic/immunologic reaction to the drug coating" as the rpn and lot number of the complaint stents are 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.According to the information provided one case of graft infection required hospitalization with intravenous antibiotics and eventual graft explant and open bypass quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Literature source: tran k, ullery bw, kret mr, lee jt, real-world performance of paclitaxel drug-eluting bare metal stenting (zilver ptx) for the treatment of femoropopliteal occlusive disease, annals of vascular surgery (2016, doi; 10.1016/j.Avsg.2016.08.006.Study location: stanford university medical centre.Description: this study was a retrospective review of clinical and angiographic data for patients treated for femoropopliteal disease with the zilver ptx stent by a single operator between 2012 and 2015.Event: one case of graft infection which required hospitalization with intravenous antibiotics and eventual graft explant and open bypass.See lines 358 to 360.Reference also related reports 3001845648-2016-00345.3001845648-2016-00346, 3001845648-2016-00347, 3001845648-2016-00348 & 3001845648-2016-00350.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING 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: 6134575
• MDR Text Key: 61102230
• Report Number: 3001845648-2016-00349
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue 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: 08/08/2016
• Event Location: Hospital
• Date Manufacturer Received: 11/08/2016
• 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