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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Device Operates Differently Than Expected (2913)

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 left leg on (b)(6) 2012.As per the above description of events received, six devices in total are involved in this incident.Five additional separate reports will be submitted in relation to the other devices reported - report reference numbers: 3001845648-2014-00291, 3001845648-2014-00292, 3001845648-2014-00293, 3001845648-2014-00294 and 3001845648-2014-00296.

Manufacturer Narrative

(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 ziv6-35-125-6.0-120-ptx stent of lot number c778569 was implanted in the pt therefore is not available for eval.With the info provided a document based investigation was carried out.No images in relation the reported event were provided.A review of the relevant mfg records revealed no discrepancies that could have contributed to the reported event.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 to (or amplifies) the restenosis process.It is very unlikely that occlusion due to a restenosis could have occurred due to zilver ptx malfunction; however a definitive root cause of this event cannot be determined.The complaint is confirmed based on customer testimony.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.According to info provided, pta was performed and the pt recovered.Qual engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead burke, unk ; 5361334440
• MDR Report Key: 4332124
• MDR Text Key: 5141322
• Report Number: 3001845648-2014-00295
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 12/03/2014
• 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: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C778569
• 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