MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DURING-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 Reocclusion (1985); Pain (1994); Surgical procedure, additional (2564)

Event Date 10/23/2013

Event Type  Injury  

Event Description

On (b)(6) 2012, three ptx stents were placed in the right sfa of a (b)(6) male patient.On (b)(6) 2013, 100% restenosis of the lesion where the stents were placed (concretely where in the three stent: unknown).Worsened claudication, worsened rutherford and rest pain were observed on the patient.On (b)(6) 2014, bypass surgery was performed against the restenosis.On (b)(6) 2014, the condition of the patient improved.This report addresses the first device reported.Two additional separate reports will be submitted in relation to the second and third device reported.Report reference number 3001845648-2015-00096 and 3001845648-2015-00097.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).This investigation addresses restenosis of the lesion where 1 xziv6-35-125-6.0-120-ptx of lot c781428 was implanted.The stent remains implanted in the patient.With the information provided, a document based investigation was carried out.According to complaint information provided, worsened rutherford, worsened claudication and rest pain were observed on the patient.The exact stage of rutherford classification is unknown, but worsened claudication and rest pain includes progression of peripheral artery disease and can be associated with the restenosis process.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 may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however a definitive cause of this event cannot be determined.Due to lack of imaging no other comments can be made.As no imaging was available to support the complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that restenosis of the stented artery and worsened claudication/rest pain are known potential adverse events associated with 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 revealed no discrepancies that could have contributed to this complaint.According to information provided, bypass surgery was performed against the restenosis and the patient's condition improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DURING-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: isnead quaid, senior specialist ; 61334440
• MDR Report Key: 4777082
• MDR Text Key: 5954317
• Report Number: 3001845648-2015-00095
• 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: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C781428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2013
• Event Location: Hospital
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2012
• 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: 61 YR