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 Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.Additional information received indicated toe amputation of the patient cannot be confirmed as the patient changed hospitals.The assessment of the patient by the reporting user facility indicated total occlusion and ulceration that this specific user facility had recommended toe amputation.The patient is currently being treated in another hospital and it is unknown if the toe amputation occurred.Adopting a conservative approach and based on the recommended amputation by this user facility and the severity of the patient's condition it is assumed the patient received the recommended treatment in another facility.Ziv6-35-125-6.0-120-ptx stent of lot number c778924 was implanted in the patient and was unavailable 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.Information provided stated that the patient had pre-existing conditions including hypercholesterolemia, hyperlipidaemia, cli (critical lower limb ischemia) and renal disease and was a previous smoker.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.From the patient¿s pre-existing conditions provided with this complaint, it is known that the patient had potential risk factors for thrombosis such as; hyperlipidaemia, hypercholesterolemia and history of tobacco use.In addition, residual inflow/outflow was evident and the site was noted as severely calcified, both of which are also contributing factors to thrombosis.There is no evidence to suggest that thrombosis did not occur, therefore, the complaint is confirmed based on customer testimony.Worsen claudication, thrombosis and ischemic ulcers were observed on the patient.It can be noted that worsen claudication indicates progression of peripheral artery disease.Total occlusion from the lesion to the periphery was also observed on the patient.The patient¿s pre-existing conditions may have contributed to the event.Additional information, provided stated that ulcerations were observed on the patient and the condition of the lower limb was so bad, toe amputation was deemed necessary.However, it is unknown if toe amputation was carried out as the patient changed hospitals and no other information was provided regarding this issue.Based on the information provided, the most likely cause of occlusion was the patient¿s pre-existing conditions.The patient had known risk factors that could have contributed to thrombosis event in this case.It is very unlikely that thrombosis could have occurred due to zilver ptx malfunction however a definitive root cause of this stent thrombosis cannot be determined and no other comments can be made.Ziv6-35-125-6.0-120-ptx stent of lot number c778924 contains zvsp6-125-6.0-120-is (zilver ptx drug eluting stent) of lot number ch755809.Zilver ptx drug eluting stent is the component involved in this complaint.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Instruction fqc0194.A review of the relevant manufacturing records (c778924 and ch755809) revealed no discrepancies that could have contributed to this complaint.No additional treatments were performed and the patient did not recover.The patient changed hospitals and no other information was provided regarding this issue.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2012, a zilver ptx stent was implanted in the right sfa of the patient.On (b)(6) 2012, angiography confirmed thrombosis.Worsened claudication and rest pain were observed to the patient.The right leg of the patient is totally occluded from the lesion to the periphery (to the foot).However, the physician plans to take no additional treatment at the moment.Additional information received on 22-oct-2015 as follows: a lot of ischemic ulcers were observed on the patient the condition of patient's lower limb was so bad that it seemed the toe needed to be amputated.However, toe amputation was not performed on that day.On the same day this was noted the patient changed the hospital and thus, no further information will be provided regarding this issue.It is unknown if amputation was performed on the patient or not.

• 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; national technology park; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5229148
• MDR Text Key: 31370480
• Report Number: 3001845648-2015-00238
• 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
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• 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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2012
• 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