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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s001.On (b)(6) 2012: three stents (ziv6-35-125-7.0-120-ptx/ c775586 x3) were placed in the right sfa.On (b)(6) 2017: 100% restenosis was confirmed in the lesion.(worsen claudication was observed.) then, pta and additional stent placement with zilver ptx were performed.The patient had a favorable outcome.Three ziv6-35-125-7.0-120-ptx stents were implanted in the patient and are therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was stated by the originator in the complaint file that there are no images available for review.The patient had the following pre-existing conditions at the time of the procedure: coronary artery disease, hypercholesterolemia and ever smoked (current smoker).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.In addition 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.Worsened claudication is also listed as a potential adverse event in the packaging insert, following the placement of this device.On review of the information provided, there is no evidence to suggest that the user did not follow the packaging insert for this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Instructions 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 not occurred previously with the lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number.Pta and additional stent placement with zilver ptx were performed.The patient had a favorable outcome.The risk associated with the complaint is moderate.No immediate action is required.

Event Description

Fda mdr report required based on surgical intervention.On (b)(6) 2012: three stents (ziv6-35-125-7.0-120-ptx/ c775586 x3) were placed in the right sfa.On (b)(6) 2017: 100% restenosis was confirmed in the lesion.(worsen claudication was observed.) then, pta and additional stent placement with zilver ptx were performed.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: 7027793
• MDR Text Key: 91911987
• Report Number: 3001845648-2017-00538
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513539
• UDI-Public: (01)10827002513539(17)140501(10)C775586
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7.0-120-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: 11/14/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/18/2017
• Date Device Manufactured: 06/11/2012
• 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