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 Problems Thrombosis (2100); Surgical procedure, additional (2564)

Event Date 08/27/2014

Event Type  Injury  

Event Description

On the (b)(4) 2012 one zfv6-35-80-6-80 and three zilver ptx stents (ziv6-35-125-6.0--120-ptx lot# unk qty: 2 and ziv6-35-125-7.0-120-ptx lot# unk qty:1) were placed in a long cto lesion in left sfa.June 2014, the pt complained of pain.On the (b)(6) 2014 ultrasonography confirmed the occlusion due to thrombosis in entire lesion where the stents were placed (in all of the four stents).On the (b)(6) 2014 treatment with a laser, removal of the thromb and pta was performed against this thrombosis, through which the patency of the vessel improved to more than 50%.This report relates to 1 x ziv6-35-125-6.0-120-ptx device.Reference also related reports 3001845548-2014-00219 and 3001845648-2014-00221.

Manufacturer Narrative

The device involved in this complaint was not available for eval (the stent remains implanted in the pt).With the info 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 info and pt's pre-existing conditions, it is known that the pt had known potential risk factors for thrombosis such as long target lesion, lesion totally occluded prior to stent placement, advanced age (81), hypertension and previous smoker.Based on the above it may be noted that the pt 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 stent thrombosis cannot be determined.The complaint is confirmed based on customer testimony.It may be noted that 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 mfg records could not be conducted as no lot number was provided.According to info provided treatment with a laser, removal of the thrombi and pta was performed against this thrombosis, through which the patency of the vessel improved to more than 50%.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: sinead quaid, sr specialist ; EI ; 61334440
• MDR Report Key: 4249615
• MDR Text Key: 5016448
• Report Number: 3001845648-2014-00220
• 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: 10/08/2014,10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Distributor Facility Aware Date: 08/27/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR