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 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s001.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Device evaluation: the ziv6-35-125-6.0-120-ptx stent of lot number c777371 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document investigation was carried out.As stated by the originator, there are no images available for evaluation.The patient had the following pre-existing conditions: hypertension, diabetes (type ii) and renal disease (renal failure).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 at the time of investigation, a definitive root cause of this event cannot be determined at this time.Worsened claudication was also observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.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.Document review: the ziv6-35-125-6.0-120-ptx stent of lot number c777371 contains zilver ptx drug eluting stent zvsp6-125-6.0-120-is of lot number ch763331.A review of the relevant manufacturing records (c777371 & ch763331) revealed no discrepancies that could have contributed to this complaint.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Pta was performed and the patient had a favourable outcome.The risk associated with the complaint is moderate.No immediate action is required.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

(b)(6) 2012: one stent (ziv6-35-125-6.0-120-ptx/ c777371) was placed in the right sfa.(b)(6) 2016: restenosis was cofirmed in the lesion.(worsen claudication and worsen rutherford were observed.) then, pta was performed and the patient had a favourable outcome.

• 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: 7024376
• MDR Text Key: 91913153
• Report Number: 3001845648-2017-00523
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140512(10)C777371
• Combination Product (y/n): N
• 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: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• 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: 11/09/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/16/2017
• 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