MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Catalog Number ZIV-35-125-6.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Surgical procedure, additional (2564)

Event Date 07/16/2014

Event Type  Injury  

Event Description

Two ziv6-35-125-6.0-120-ptx and one ziv6-35-125-7.0-120-ptx stents were placed on the right leg on (b)(6) 2012.Two ziv6-35-125-6.0-120-ptx and one ziv6-35-125-6.0-60-ptx stents were then placed on the left leg on (b)(6) 2012.On (b)(6) 2014 restenosis and worsen rutherford was confirmed in both legs.Pta was performed on both legs on the same day.The pt recovered on (b)(6) 2014.This report is in relation to one of the ziv6-35-125-6.0-120-ptx devices placed on the right leg on (b)(6) 2012.As per the above description of events received, six devices in total are involved in this incident.Five add'l separate reports will be submitted in relation to the other devices reported.(b)(4).

Manufacturer Narrative

Pma/510 (k) #: (b)(4).Incident requires fda mdr report based on the surgical intervention carried out due to the occurrence of restenosis in the lesion where a ptx stent was indwelling.The device involved in this complaint is as follows: ziv6-35-125-6.0-120-ptx of lot number c778568.The stent in question remains implanted in the pt and therefore is not available for eval.With the info provided, a document based investigation was carried out.No images in relation to the reported event were provided.It may be noted that restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads (or amplifies) to the restenosis process.Restenosis of the stented artery is a known potential adverse event associated with the placement 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 devices revealed no discrepancies which could have contributed to this complaint issue.Due to the lack of images for review and as the conditions of use cannot be replicated in a laboratory setting, it is not possible to conclusively determine the root cause for this complaint at this time.The complaint is confirmed based on customer testimony.As per the info provided following pta, the pt recovered.The risk associated with this complaint has been assessed by quality engineering and determined to be low.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead burke ; 3536133444
• MDR Report Key: 4317487
• MDR Text Key: 17571920
• Report Number: 3001845648-2014-00292
• 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: Physician
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2014
• Device Catalogue Number: ZIV-35-125-6.0-120-PTX
• Device Lot Number: C778568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2012
• 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: 66 YR