MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number ZIV6-35-80-8-60

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/26/2013

Event Type  Injury  

Event Description

A zilver vascular stent was initially placed on (b)(6) 2011 in the left common and left external iliac artery.A ct scan on (b)(6) 2013 noted the stent fractured in three places which is leading to a type 1b endoleak from an evar.The graft placed for the evar was not a cook graft but the stent is a cook device.The surgeon is planning to implant a covered stent to re-align the stent in (b)(6).The pt was on outpatient status and stable.On the (b)(6) 2014, a stent graft limb (medtronic) was implanted to address the type 1b leak.

Manufacturer Narrative

Images relating to this complaint were received and have been sent for review to med institute.Upon receipt of the med institute review, the investigation will be amended and a f/u report will be submitted.The complaint info provided indicated the device involved in this complaint to be a zilver vascular stent.The exact rpn is unk.The rpn ziv6-35-80-8-60 was used for purposes of completing the complaint investigation and regulatory reports.A zilver vascular stent was initially placed on (b)(6) 2011 in the left common and left external iliac artery.A ct scan on (b)(6) 2013 noted the stent fractured in three places which is leading to a type 1d endoleak from an evar.The pt was on outpatient status and was stable.On the (b)(6) 2014, a stent graft limb (medtronic) was implanted to address the type 1b leak.The complaint info provided indicated the device involved in this complaint to be a zilver vascular stent.The exact rpn is unk.As the lot number was not provided; it was therefore not possible to establish if there were any devices from the affected lot numbers in stock at the time of the complaint investigation.A document based investigation was carried out as the complaint device was not available for eval.A review of the mfg records for this device could not be carried out as the lot number was not provided.Prior to distribution all ziv6-35-80-8-60 devices are subject to visual inspection and functional checks to ensure device integrity.Images in relation to this complaint have been received and sent for review to med institute.Upon receipt of the med institute review the investigation will be amended and a f/u report will be submitted.Stent strut fracture is a known potential adverse effect as per the instructions for use for this device.As the device was not available to be returned, the cause of the complaint could not be conclusively determined.Customer quality assurance will continue t monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; limerick ; EI ; 61334440
• MDR Report Key: 3624775
• MDR Text Key: 4174992
• Report Number: 3001845648-2014-00009
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050017
• 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: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-80-8-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/26/2013
• Event Location: Hospital
• Date Manufacturer Received: 12/30/2013
• 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