MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Reocclusion (1985); Surgical procedure, additional (2564)

Event Date 04/01/2015

Event Type  Injury  

Event Description

(b)(4), patient (b)(6): on (b)(6) 2015, the patient was diagnosed with an occlusion/restenosis in the left distal sfa within the study lesion.Treatment included balloon angioplasty and stent placement.The physician indicated that the event was thought to definitely be related to the study product and that the pre-existing condition of peripheral vascular disease caused or contributed to the event.It is unknown if imaging is yet available.This report addresses one ziv6-35-125-6-80-ptx stent.An additional separate report has been submitted in relation to the second stent.Report reference number 3001845648-2015-00120.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.(b)(4).The info received relating to this event is currently being investigated.A follow-up report will be submitted with the investigation conclusions.

Manufacturer Narrative

The ziv6-35-125-6-80-ptx stent of lot number c936398 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were available to support the complaint investigation.The following comments were provided by the independent reviewer "findings:.Year follow up ultrasound demonstrated mild neointimal hyperplasia on color flow doppler but no significant stenosis on pulse wave doppler.Fourteen months later severe stenosis on color flow and pulse wave doppler developed in the mid to distal stented segment.Mild stenosis was present in the proximal stented segment.Impression:.Although no imaging from the complaint event was provided, two months prior to the occlusion the mid to distal stented segment was severely narrowed from neointimal hyperplasia.Factors increasing restenosis occlusion risk include an untreated stenosis, poor runoff, long stented length, small vessels, and severe atherosclerotic disease".Based on the image review, the customer complaint could be confirmed as two months prior to the occlusion the mid to distal stented segment was severely narrowed from neointimal hyperplasia.It can be noted that neointimal hyperplasia is the major cause of restenosis that occurs after interventions such as stenting or angioplasty.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e g dunng 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.According to the independent reviewer, factors increasing restenosis occlusion risk include an untreated stenosis, poor runoff, long stented length, small vessels, and severe atherosclerotic disease.Moreover, the physician has indicated that the pre-existing condition of peripheral vascular disease caused or contributed to the event.It can be therefore stated that it is very unlikely that the event could have occurred due to zilver ptx malfunction.As per instruction for use, restenosis of the stented artery is a known potential adverse event associated with the 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.Treatment included balloon angioplasty and stent placement.No adverse effects to the patient have been reported.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This f/u report is being submitted to include the investigation conclusions.Protocol 12-004 patient (b)(6).On (b)(6) 2015, the pt was diagnosed with an occlusion/restenosis in the left distal sfa within the study lesion.Treatment included balloon angioplasty and stent placement.The physician indicated that the event was thought to definitely be related to the study product and that the pre-existing condition of peripheral vascular disease caused or contributed to the event.It is unknown if imaging is yet available.This report addresses one ziv6-35-125-6-80 ptx stent.An additional separate report has been submitted in relation to the second stent.Report reference number 3001845648-2015-00120.The event end date was noted to be (b)(6) 2015.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; 61334440
• MDR Report Key: 4840238
• MDR Text Key: 5871421
• Report Number: 3001845648-2015-00124
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2013
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Device Lot Number: C936398
• Other Device ID Number: 0110827002248905(17)131207(10)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2013
• 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: 72 YR