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

Catalog Number ZIV6-35-125-7.0-40-PTX

Device Problem Insufficient Information (3190)

Patient Problems Thrombosis (2100); Claudication (2550); Surgical procedure, additional (2564)

Event Date 11/12/2013

Event Type  Injury  

Event Description

On (b)(6) 2012 two ziv6-35-125-6.0-120-ptx and one ziv6-35-125-7.0-40-ptx were implanted in the right sfa of the patient.Dissection occurred and was untreated at that time.On (b)(6) 2013 angiography confirmed the thrombosis at the lesion where the stents were placed.Patient showed symptoms of worsened claudication, rest pain and persistent claudication.On (b)(6) 2014 pta and stent placement for thrombosis were performed.On (b)(6) 2014 there have been no further adverse effects to the patient reported as occurring as a result of this specific event.This report relates to 1x ziv6-35-125-7.0-40-ptx of lot# c772908.Reference also related mdr reports 3001845648-2014-00272 and 3001845648-2014-00273.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).This investigation addresses 1xziv6-35-125-7.0-40-ptx of lot# c772908.Reference also related mdr reports 3001845648-2014-00272 and 3001845648-2014-00273.The 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.To date the review of images relating to this event has not been received.From the complaint information and patient's pre-existing conditions it is known that the patient had known potential risk factors for thrombosis such as: hypertension, hypercholesterolemia and renal failure.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.As no image review was available to support the complaint investigation the complaint is confirmed on customer testimony.It may be noted that thrombosis is a known potential adverse effect of the use of this device.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 for zilver ptx and zilver ptx drug eluting stent (lot numbers specified above) revealed no discrepancies that could have contributed to this complaint.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, senior specialist ; 61334440
• MDR Report Key: 4314861
• MDR Text Key: 5250619
• Report Number: 3001845648-2014-00271
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Unknown
• Type of Report: Initial
• Report Date: 10/28/2014

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 Expiration Date: 10/21/2013
• Device Catalogue Number: ZIV6-35-125-7.0-40-PTX
• Device Lot Number: C772908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2012
• 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): Required Intervention
• Patient Age: 76 YR