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

Catalog Number ZIV6-35-125-6.0-60-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 06/03/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The ziv6-35-125-6.0-60-ptx stent of lot numbers c777742 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.A request to determine if imaging is available is currently pending for this patient.The investigation will be updated when a response is received.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 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 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 as per the packaging insert, 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.Upon review of complaints, this failure mode has occurred previously with the lot number c777742.However based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c777742.Poba was performed, but reocclusion was not resolved.Cilostazol and dorner were additionally administered.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012, ziv6-35-125-6.0-60-ptx/ c777742 x 3 were placed in the left distal sfa.Also, another manufacturer's stent placement (resolute/ by medtronic) was conducted in the left pta but the resolute was placed with the distal part bent into the false lumen unintentionally.The procedure was finished without any treatment for the resolute.Blood flow confirmed below knee was only in the ata.On (b)(6) 2014, follow-up confirmed restenosis of all the ptx stents (3 pcs).Then, poba (4 mm) was performed in the ptxs and another manufacturer's stent (misago 6x40/ by terumo) was additionally placed more distal side than ptxs.On (b)(6) 2014, the patient was discharged from the hospital.On (b)(6) 2014, misago stent and previously placed ziv6-35-125-6.0-60-ptx/ c777742 x 3 were 100% restenosed.Poba was performed, but reocclusion was not resolved.On (b)(6) 2014, since abi was 0.35, cilostazol and dorner were additionally administered.The physician decided to take a wait-and-see approach with medication.Currently (date unknown), claudication was observed.Please note as three zilver ptx devices are reported as involved in this event ((b)(6) 2014) a separate report was submitted for each suspect device.Reference related reports: 3001845648-2017-00239 and 3001845648-2014-00241.Please note 3 additional related reports were submitted for the event that occurred on ((b)(6) 2014).Reference related reports: 3001845648-2014-00180, 3001845648-2014-00181 and 3001845648-2014-00182.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted due to the receipt of an updated complaint description of this event.The ziv6-35-125-6.0-60-ptx stent of lot numbers c777742 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.It was determined that there is no imaging available for review.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 is available, a definitive root cause of this event cannot be determined at this time.In addition 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 as per the packaging insert, 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.Upon review of complaints, this failure mode has occurred previously with the lot number c777742.However based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c777742.Poba was performed, but reocclusion was not resolved.Cilostazol and dorner were additionally administered.The patient had a favourable outcome.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

This follow up report is being submitted due to the receipt of an updated complaint description of this event.Corrected/updated information provided on 6/sep/2017: on (b)(6) 2014, misago stent and previously placed ziv6-35-125-6.0-60-ptx/ c777742 x 3 were 100% restenosed.Poba was performed, but reocclusion was not resolved.(rest pain was observed.) on (b)(6) 2014, the patient has not recovered.Worsen claudication or rest pain was observed, so medication(s) was /were changed (since abi was 0.35, cilostazol and dorner were additionally administered).The physician decided to take a wait-and-see approach with medication.On (b)(6) 2016, the patient had a favourable outcome.Please note as three zilver ptx devices are reported as involved in this event ((b)(6) 2014) a separate report was submitted for each suspect device.Reference related reports: 3001845648-2017-00239 and 3001845648-2014-00241.

• 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: 6669783
• MDR Text Key: 78473961
• Report Number: 3001845648-2017-00240
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513423
• UDI-Public: (01)10827002513423(17)140419(10)C777742
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• 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,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-60-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/06/2017
• Date Device Manufactured: 06/18/2012
• 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