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 10/04/2016

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 following 12 complaint files were opened for this patient: pr204603 ¿ restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c775583 on the (b)(6) 2016.Pr204605 ¿ restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c776874 on the (b)(6) 2016.Pr204606 ¿ restenosis of ziv6-35-125-7.0-60-ptx stent of lot number c772905 on the (b)(6) 2016.Pr204607 ¿ restenosis of ziv6-35-125-7.0-40-ptx stent of lot number c772908 on the (b)(6) 2016.Pr204608 ¿ restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c775583 on the (b)(6) 2017.Pr204609 ¿ restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c776874 on the (b)(6) 2017.Pr204610 ¿ restenosis of ziv6-35-125-7.0-60-ptx stent of lot number c772905 on the (b)(6) 2017.Pr204611 ¿ restenosis of ziv6-35-125-7.0-40-ptx stent of lot number c772908 on the (b)(6) 2017.Pr204612 ¿ restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c775583 on the(b)(6) 2017.Pr204613 ¿ restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c776874 on the (b)(6) 2017.Pr204614 ¿ restenosis of ziv6-35-125-7.0-60-ptx stent of lot number c772905 on the (b)(6) 2017.Pr204616 ¿ restenosis of ziv6-35-125-7.0-40-ptx stent of lot number c772908 on the (b)(6) 2017.This investigation deals with the restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c776874 on the (b)(6) 2016.The ziv6-35-125-6.0-120-ptx stent of lot number c776874 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 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: carotid artery disease, hypertension, hypercholesterolemia, renal failure, previous smoker (current: not).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.Document review: the ziv6-35-125-6.0-120-ptx stent of lot number c776874 contains zilver ptx drug eluting stent zvsp6-125-6.0-120-is of lot number ch762615.A review of the relevant manufacturing records (c776874 & ch762615) 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 conducted against the restenosis on the same day and the condition of the patient was improved.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.Four ptx stents below were implanted in the left sfa of a male patient.Ziv6-35-125-6.0-120-ptx lot#c775583.Ziv6-35-125-6.0-120-ptx lot#c776874.Ziv6-35-125-7.0-60-ptx lot#c772905.Ziv6-35-125-7.0-40-ptx lot#c772908.(b)(6) 2016.100% restenosis of the stented lesion was confirmed.Worsened intermittent claudication and worsened rutherford were observed on the patient (pr204603, 204605, 204606, 204607).Pta was conducted against the restenosis on the same day and the condition of the patient was improved.(b)(6) 2017.100% restenosis of the stented lesion was confirmed.Worsened intermittent claudication and worsened rutherford were observed on the patient (pr204608, 204609, 204610, 204611).Pta was conducted against the restenosis on the same day and the condition of the patient was improved.(b)(6) 2017.100% restenosis of the stented lesion was confirmed.Worsened intermittent claudication and worsened rutherford were observed on the patient(pr204612, 204613, 204614, 204616).Pta was conducted against the restenosis on the same day and the condition of the patient was improved.This investigation deals with the restenosis of ziv6-35-125-6.0-120-ptx stent of lot number c776874 on the (b)(6) 2016.

• 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: 7024402
• MDR Text Key: 91907880
• Report Number: 3001845648-2017-00526
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140504(10)C776874
• 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: 11/13/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/16/2017
• Date Device Manufactured: 06/14/2012
• 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: 78 YR