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

Catalog Number ZIV6-35-80-6.0-100-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Reocclusion (1985); No Code Available (3191)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ziv6-35-80-6.0-100-ptx devices are not cleared / approved in the us but are considered similar to other devices currently available on the market.Pma/510(k) #p100022/s001.The ziv6-35-80-6.0-100-ptx stent of lot number c1234406 was implanted in the patient, therefore is not available for evaluation.With the information provided a document based investigation was carried out.It may be noted that there was already an mdr report submitted in relation to the thrombosis event that occurred on the 09-jul-2016, ref#3001845648-2016-00225 for investigation details.This investigation addresses the thrombosis event that occurred on the (b)(6) 2017.It is known the patient had the following pre-existing conditions at the time of the procedure: patient history of coronary artery disease, hypercholesterolemia, and smoking (quit).The patient was enrolled in the study to treat the left proximal superficial femoral artery (sfa).The right rutherford classification was two.The patient was taking aspirin at the time of the procedure.Procedural angiography noted severe calcification and no thrombus in the study lesion.The inflow tract was patent and there was one patent runoff vessel.The lesion length was 60 mm with a proximal reference vessel diameter (rvd) of 5.0 and a distal rvd of 5.0 mm.The percent diameter stenosis in the study lesion was 80% there is no imaging available to support this investigation, as stated in the complaint file imaging is not collected in this (b)(6) study.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It is unlikely that the reported thrombosis occurred due to device malfunction, however due to lack of imaging and as the conditions of use cannot be replicated, a definitive root cause cannot be determined and no other comments can be made.It may be noted that as per the instructions for use arterial thrombosis 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 this lot number; however it occurred on the same patient.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1234406.According to information provided, the patient had a ¿prosthetic femoral popliteal bypass¿ performed.The original study lesion was bypassed.The patient was discharged from the hospital on (b)(6) 2017.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

(b)(6), thrombosis within the study lesion on (b)(6) 2016, following bare balloon angioplasty, a 6 mm x 100 mm zilver ptx stent (g55294; c1234406) was placed in the left proximal sfa.There was no difficulty using the stent or delivery system.There was no residual stenosis in the study lesion.On (b)(6) 2016 (two days post-procedure), thrombosis was identified within the study lesion (left proximal sfa) by ultrasound imaging.The patient was not experiencing clinical symptoms.The patient underwent endovascular intervention that included angioplasty and thrombectomy.The investigator noted that the event was probably related to the study device and definitely related to the study procedure.The site responded no to the question: did the device malfunction or deteriorate in characteristics or performance? addition 03-jul-2017: on (b)(6) 2017, (237 days post-procedure), the patient was hospitalized due to thrombosis of the study vessel.The location was the study lesion (including up to 5 mm proximal and/or distal to study lesion).The patient experienced rapid clinical symptoms and angiographic appearance was highly suggestive of thrombus with a percentage diameter stenosis of 100 %.The patient had a ¿prosthetic femoral popliteal bypass¿ performed.The original study lesion was bypassed.A pre-existing cause of atherosclerosis was noted to contribute to the event and the event was noted to probably be related to the device.The patient was discharged from the hospital on (b)(6) 2017.

• 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: 6746828
• MDR Text Key: 81234512
• Report Number: 3001845648-2017-00307
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002552941
• UDI-Public: (01)10827002552941(17)180412(10)C1234406
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-80-6.0-100-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/27/2017
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76