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

Catalog Number ZIV6-35-125-6-60-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stenosis (2263); Surgical procedure, additional (2564)

Event Date 01/05/2015

Event Type  Injury  

Event Description

A (b)(4) patient presented with leg pain.The initial placement of the zilver ptx stent was considered successful.However, the patient's symptoms worsened (pain and numbness distal to the stent) and the patient returned to the physician's office.The patient had an arteriogram which demonstrated stenosis of the right femoral artery.The plan was to proceed with an angioplasty, but the patients diastolic blood pressure was 110, so the procedure was aborted.The patient was referred to (b)(6) for a medical evaluation to control his hypertension and presents for follow up evaluation on the (b)(6) 2014.The patient brought a copy of his blood pressure from (b)(6) 2014 which demonstrated pretty good control until (b)(6) 2014 when his blood pressure elevated.He continued to complain of severe right lower extremity lifestyle limiting claudication and was able to work.Patient had discontinued smoking for 28 days at this point.Patient denies chest pains or shortness of breath.On the (b)(6) 2015, an infusion catheter was placed inside the thrombosis within the zilver ptx stent.Tpa was dripped for 24 hours.On (b)(6) 2015, angioplasty was carried out and the zilver ptx was confirmed to be patient.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).The zilver device involved in this complaint was not available for evaluation.The stent remains implanted in the patient.With the information provided a document based investigation was carried out.Images were requested to support the complaint investigation; however, to date no images were provided.From the complaint information provided, patient's office notes and patient's pre-existing conditions it is known that the patient had known potential risk factors for thrombosis such as obesity, hypertension, high grade stenosis and history of tobacco use (20 years).Based on the above it may be noted that the patient had some 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 event cannot be determined and no other comments can be made.As no images were available to support the complaint investigation the complaint is confirmed based on customer testimony.It may be noted that stent thrombosis is a known potential adverse effect as per the instructions for use.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.According to information provided, on the 14 jan 2015 angioplasty was carried out and the zilver ptx was confirmed as patent.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid,senior reg affairs ; 61334440
• MDR Report Key: 4487403
• MDR Text Key: 18034385
• Report Number: 3001845648-2015-00016
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2015
• Device Catalogue Number: ZIV6-35-125-6-60-PTX
• Device Lot Number: C1007666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• 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: 58 YR
• Patient Weight: 86