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 Insufficient Information (3190)

Patient Problems Amputation (1702); Thrombosis (2100)

Event Date 09/06/2013

Event Type  Injury  

Event Description

On (b)(6) 2012, two ziv6-35-125-6.0-120-ptx stents were implanted in the right upper sfa.On (b)(6) 2013, thrombosis was diagnosed by contrast-enhanced ct.Gastrointestinal bleeding was also confirmed.Above-the-knee amputation was performed and the stents were removed.On (b)(6) 2013, right femoral - popliteal bypass was performed.On (b)(6) 2013, the patient was transferred to another hospital.As per the above description two zilver ptx devices are reported as involved in this incident.A report has been submitted in relation to the first device.Reference report # 3001845648-2014-00053.

Manufacturer Narrative

On (b)(6) 2010, two ziv6-35-125-6.0-120-ptx stents were implanted in the right upper sfa.On (b)(6) 2013, thrombosis was diagnosed by contrast-enhanced ct.Gastrointestinal bleeding was also confirmed.Above-the-knee amputation was performed and the stents were removed.On (b)(6) 2013, right femoral - popliteal bypass was performed.The device involved in this complaint is: 1 x ziv6-35-125-6.0-120-ptx (lot number c785081).The other stent implanted on (b)(6) 2012 has been address and submitted in a separate report.Reference report # 3001845648-2014-00053.There were no zilver ptx devices of lot numbers c785081 in stock at the time of the complaint investigation.A document based investigation was carried out as the device is not available for evaluation.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 ages, 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, mon-responder to the apt, or non-compliant with prescribe regimen.According to the info provided, th patient had the following known potential risk factors for thrombosis: hypertension, hemodialysis, advanced age ((b)(6)) and was a smoker.Coronary artery disease, renal disease & gastrointestinal bleeding were also confirmed.In addition, info provided in thrombosis questionnaire revealed that there was evidence of residual inflow and outflow, compromised flow due to proximal stenosis, distal stenosis and the degree of calcification was moderate to severe.The minimum lumen diameter pre-procedure according to the thrombosis questionnaire was 0.15mm and according to the initial reporter the target lesion was 99% stenosed and its length was approximately 20cm.It was also stated that the stent was used to treat a segment in a diffusely diseased vessel.It can be noted that the patient was on the antiplatelet therapy prior to and after the procedure therefore medication factor is not a contributing factor to stent thrombosis in this case.Based on the above, it may be noted that the patient had a number of risk factors that could have contributed to the thrombosis event.It is unlikely that thrombosis could have occurred due to zilver ptx malfunction however a definitive root cause of this event cannot be determined.As per the info provided the patient recovered.Images were requested but have not yet been provided.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in the procedure referenced above.A review of the manufacturing records for zilver ptx and zilver ptx drug eluting stent revealed no discrepancies that could have contributed to this complaint.As per instructions for use thrombosis is noted as potential adverse event associated with the placement of this device.Since there are no images available for review, there is no evidence to suggest that thrombosis did not occur; therefore the complaint is confirmed based on customer testimony.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; EI ; 61334440
• MDR Report Key: 3735757
• MDR Text Key: 17157235
• Report Number: 3001845648-2014-00052
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C785081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2013
• Event Location: Hospital
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2012
• 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): Disability
• Patient Age: 78 YR