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 Problems Pain (1994); Claudication (2550); Surgical procedure, additional (2564)

Event Date 10/23/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 - 1 (b)(4) ptx stent was placed in th left sfa of a (b)(6) male patient.On (b)(6) 2013, 100% restenosis was confirmed on the lesion where the stent was placed.Worsened claudication, worsened rutherford and rest pain were observed on the patient.On (b)(6) 2014 bypass surgery was performed against the restenosis.On (b)(6) 2014 the condition of the patient improved.There have been no further adverse effects to the patient reported.

Manufacturer Narrative

(b)(4).The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.

Event Description

This follow up report is being submitted to include the investigation conclusions.On (b)(6) 2013 - 1 x ziv6-35-125-6.0-120-ptx stent was placed in the left sfa of a (b)(6) male patient.On (b)(6) 2013 - 100% restenosis was confirmed on the lesion where the stent was placed.Worsened claudication, worsened rutherford and rest pain were observed on the patient.On (b)(6) 2014 - bypass surgery was performed against the restenosis.On (b)(6) 2014 - the condition of the patient improved.There have been no further adverse effects to the patient reported.

Manufacturer Narrative

(b)(4).The ziv6-35-125-6.0-120-ptx of lot number c780695 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were requested to support the complaint investigation, however it has been confirmed that no images will be provided.According to complaint information provided, worsened claudication, worsened rutherford and rest pain were observed on the patient.It can be noted that these symptoms indicates progression of peripheral artery disease and can also be associated with restenosis process.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During 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 a definitive cause of this event cannot be determined.Due to lack of imaging no other comments can be made.As no imaging was available to support the complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that worsened claudication / rest pain and restenosis of the stented artery are known potential adverse events associated with 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.According to information provided bypass surgery was performed against the restenosis and the condition of the patient improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.(b)(4).The ziv6-35-125-6.0-120-ptx of lot number c780695 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were requested to support the complaint investigation, however it has been confirmed that no images will be provided.According to complaint information provided, worsened claudication, worsened rutherford and rest pain were observed on the patient.It can be noted that these symptoms indicates progression of peripheral artery disease and can also be associated with restenosis process.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During 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 a definitive cause of this event cannot be determined.Due to lack of imaging no other comments can be made.As no imaging was available to support the complaint investigation, the complaint is confirmed based on customer testimony.It may be noted that worsened claudication / rest pain and restenosis of the stented artery are known potential adverse events associated with 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.According to information provided bypass surgery was performed against the restenosis and the condition of the patient improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow-up mdr is being submitted to provide details of the investigation conclusion due to confirmation on (b)(6) 2015 that with the implementation of emdrs page 3 of our submission was not transmitted to emdrs and only information has been submitted.Any information that was included in on page 3 of our previous submission has now been copied, reference additional mfg narrative - notes for details.On (b)(6) 2013 - 1 x ziv6-35-125-6.0-120-ptx stent was placed in the left sfa of a (b)(6) male patient.On (b)(6) 2013 - 100% restenosis was confirmed on the lesion where the stent was placed.Worsened claudication, worsened rutherford and rest pain were observed on the patient.On (b)(6) 2014 - bypass surgery was performed against the restenosis.On (b)(6) 2014 - the condition of the patient improved.There have been no further adverse effects to the patient reported.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 4941935
• MDR Text Key: 6638504
• Report Number: 3001845648-2015-00145
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2015,09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C780695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2013
• Event Location: Hospital
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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: 61 YR