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

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

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s001.This investigation captures the restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c777375 on the 15-june-2017.Ref also: 3001845648-2017-00503.The device was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator that there are no images available for review.It is known the patient had the following pre-existing conditions: coronary artery disease, hypertension, diabetes, hypercholesterolemia and renal disease.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (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 as no imaging was available for review, a definitive root cause of this event cannot be determined.It may be noted that the packaging insert lists restenosis of the stented artery as a known potential adverse event associated with placement of this device.In addition worsened claudication is also listed as a potential adverse event associated with the placement in this device as per the packaging insert.A query is currently pending with the rep on where exactly the restenosis occurred (which stent? proximal or distal stent?) and if these two stents overlapped.The investigation will be updated on receipt of this information 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.Upon review of complaints, this failure mode has occurred previously with the lot number c777375.However, based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c777375.Therefore no action required.The patient was treated with a cutting balloon and the patient recovered.No other adverse events were reported as a result of this occurrence.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012: two stents (ziv6-35-125-6.0-120-ptx/ c777375 + ziv6-35-125-7.0-60-ptx/ c774345) were placed in the left sfa.On (b)(6) 2017: restenosis was confirmed in the lesion.(worsen claudication were observed.) then, the restenosed site was treated with a cutting balloon and the patient recovered.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6999314
• MDR Text Key: 90977284
• Report Number: 3001845648-2017-00502
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140504(10)C777375
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/05/2017
• Date Device Manufactured: 06/16/2012
• 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