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

Catalog Number ZIV6-35-125-7-80-PTX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Thrombosis (2100); Surgical procedure, additional (2564)

Event Date 04/29/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 the patient was diagnosed with a thrombus in the right sfa within the study lesion.The thrombus was identified via angiography and the angiographic appearance was highly suggestive of thrombus.The patient had experienced rapid onset of clinical signs and symptoms.Treatment included thrombectomy and thrombolysis.The physician indicated that the event was thought to possibly be related to the study product and that the pre-existing condition of peripheral vascular disease caused or contributed to the event.The patient was hospitalized for the event.The event end date was noted to be (b)(6) 2015.

Manufacturer Narrative

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

Manufacturer Narrative

This follow up report is being submitted to include the investigation conclusions.The ziv6-35-125-7-80-ptx stent of lot number c985530 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation.These were reviewed through med institute and the following comments were provided by the independent reviewer."findings: procedural angiography and 12 month follow up x-rays and ultrasound is provided along with the complaint report.The secondary intervention performed at 11 months is not provided.The angiography from the intervention reported necessary to treat abrupt recurrent symptoms dated (b)(6) 2015 was not provided.X-rays post-secondary intervention (b)(6) 2015 demonstrated a viabahn stent spanning from 46mm proximal to 25mm distal the zilver ptx stent.In the lateral projection, 30% diameter stenosis was present anterior to posterior from the heavily calcified plaque.In the anterior posterior projection, viabahn was constrained 2mm inside the zilver ptx stent given the reported thrombectomy and thrombolysis this likely represented neointimal hyperplasia.Follow-up ultrasound the same day demonstrated no significant stenosis on duplex, color flow doppler, and pulse wave doppler ultrasound proximally from the right external iliac artery, through the stent, to distally through the popliteal artery." impression: since no imaging from the secondary intervention is provided, in-stent thrombosis cannot be directly confirmed indirect evidence of a primarily thrombotic event is supported by evidence of only mild neointimal hyperplasia in between the zilver ptx and viabahn stents on the follow up x-ray.Because of the large native sfa diameter, minimal zilver ptx stent diameter was still 4 8mm in the areas of 30% residual stenosis.Consequently, thrombosis and restenosis risk from these areas would have been low.The most likely cause of acute thrombosis was transient stent kinking from knee flexion.Upon review of the available images, in-stent thrombosis cannot be directly confirmed as imaging from the secondary intervention was not provided.However, there is no evidence to suggest that thrombosis event did not occur, therefore the complaint is confirmed based on customer testimony.From the information provided with this complaint.It is known that the physician indicated that the pre-existing condition of peripheral vascular disease could have contributed to the event.Moreover, according to the opinion of independent reviewer, the most likely cause of acute thrombosis was transient stent kinking from knee flexion.Based on the above, it can be therefore concluded that it is unlikely that thrombosis occurred due to zilver ptx malfunction.However, a definitive root cause of this event cannot be determined.It may be noted that thrombosis is known potential adverse effect as per instruction for use.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, the patient was hospitalized for the event (thrombectomy and thrombolysis were conducted).Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, senior specialist ; 61334440
• MDR Report Key: 4870761
• MDR Text Key: 6047504
• Report Number: 3001845648-2015-00129
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248950
• UDI-Public: (01)10827002248950(17)150212(10)C985530
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Unknown
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2015
• Device Catalogue Number: ZIV6-35-125-7-80-PTX
• Device Lot Number: C985530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR