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 Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/08/2016

Event Type  Death  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.From the median 11.1 month follow up (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 pr addresses one procedural related death in this study.It was due to hemorrhagic stroke following stent graft thrombolysis.This patient initially presented with one block claudication despite exercise therapy with a corresponding abi (ankle-brachial indices) of.60 for which the patient elected to pursue endovascular treatment.Clinical input was requested in regard to the "stent graft thrombolysis".The following input was provided."typically the term ¿stent graft¿ is used to describe a covered stent of some type, and not a bare stent or drug-eluting stent.It¿s confusing in this article because they use the term ¿stent graft¿ when specifically discussing a zilver ptx device.I figured that was just the author mis-speaking and using the term stent-graft incorrectly." the patient represented to clinic at four months with occluded zilver ptx stents, and was retreated with local pharmacologic thrombolysis and placement of an overnight thrombolytic infusion catheter.Shortly after removal of the infusion catheter, the patient was noted to have severe right sided hemiparesis and found to have a large hemispheric stroke on the left.The patient had no history of a prior stroke, atrial fibrillation or bleeding disorders.The below list indicates potential risk factors that can generally contribute to the thrombosis event: patient factors; history of coagulopathy/prior thrombosis (e.G., dvt); diabetes, especially if poorly controlled; cancer/chemotherapy; advanced age; obesity, hyperlipidemia, hypertension; smoking.Lesion factors: long lesion, small vessel diameter, severe calcification; lesion totally occluded prior to stent placement; placement for in stent restenosis.Procedure factors: residual inflow, outflow, or in-segment stenosis or dissection; poor run off (i.E., beyond trifurcation).Medication factors: inadequate procedural heparinization; inadequate loading dose of antiplatelet (ticlopidine or clopidogrel); inadequate dapt prescribed; non-responder to the apt, or non-compliant with prescribe regimen.As per the article, all patients received a minimum twelve months of dual-antiplatelet therapy with aspirin and clopidogrel unless contraindicated.Clopidogrel was discontinued after 6-12 weeks for patients suffering from minor hemorrhagic events.Significant hemorrhagic complications prompted immediate discontinuation of clopidogrel.The rpn and lot numbers of the stents involved in this study are unknown.From information provided in the article, it is known that the study population had the following risk factors for thrombosis; 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.It can be noted that according to the article, coronary artery disease (hazard ratio (hr) 6.99, confidence interval (ci) 0.77-63.0), chronic renal insufficiency (hr 18.1, ci 2.01-163.2), wifi (svs wound ischemia and foot intervention) score (hr 3.03, ci 1.13-8.12) and use of 7mm diameter stents (hr 5.53, 0.90-33.7), longer treated lesion lengths (hr 2.51 per 10cm, 1.18-5.3) as possible dependent factors affecting risk of male.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.As per cook clinical reviewer: stent thrombosis is a risk with any vascular stent, including the zilver ptx, with the risk of thrombosis of zilver ptx stents appearing to be similar to bms used in the sfa.Stent thrombosis is commonly treated with mechanical thrombectomy devices to remove the clot and/or catheter-based infusions of lytic drugs that breakdown the clot.The risk of using lytic drugs is that they can then circulate throughout the body, potentially causing bleeding at other sites in the body.The use of catheter-directed infusion allows smaller doses of drug to be used, lessening the risk of bleed, but the risk still remains.It would appear that this patient had no other particular risk factors for a bleed in their brain (hemorrhagic stroke), and as such the bleed was attributed to the lytic drugs given to treat the thrombosed stent.So the stent didn¿t directly cause the bleed, but the fact that it thrombosed resulted in the need for lytic agents to be used, which in turn resulted in the complication of hemorrhagic stroke.This cascade of events could potentially have happened with any stent used in the sfa, and is no more likely to occur with the zilver ptx than with other stents.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.As per the instructions for use, arterial thrombosis is a known potential adverse event associated with placement of this device.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 death was due to intracranial hemorrhage associated with catheter-directed thrombolysis for stent occlusion.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(4).(b)(6).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.¿the authors would like to highlight that one procedural related death in this study which was due to hemorrhagic stroke following stent graft thrombolysis.This patient initially presented with one block claudication despite exercise therapy with a corresponding abi of.60 for which he elected to pursue endovascular treatment.He represented to clinic at four months with occluded zilver ptx stents, and was retreated with local pharmacologic thrombolysis and placement of an overnight thrombolytic infusion catheter.Shortly after removal of the infusion catheter, he was noted to have severe right sided hemiparesis and found to have a large hemispheric stroke on the left.He had no history of a prior stroke, atrial fibrillation or bleeding disorders.These rare cases of significant adverse events underscore the importance of reporting safety outcomes following any intervention involving new technology for pad treatments." reference also related reports 3001845648-2016-00346, 3001845648-2016-00347, 3001845648-2016-00348, 3001845648-2016-00349 & 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: 6131839
• MDR Text Key: 61018775
• Report Number: 3001845648-2016-00345
• 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: 11/29/2016
• 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
• 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): Death