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 Reocclusion (1985); Claudication (2550)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001.The ziv6-35-125-6.0-120-ptx stent of lot number c776875 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.As stated by the originator in the complaint file, no further information will be provided, and no images are available for review.The patient had the following pre-existing conditions:smoker.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It can be noted that smoking has been listed as potential risk factor for thrombosis.It is possible that the patient had some additional risk factors identified above and these could have caused or contributed to the reported event.However, as the patient pre-existing conditions are unknown and very limited information is available, a cause of the reported thrombosis remains unknown and no other comments can be made.It may be noted that the packaging insert lists thrombosis of the stented artery as a known potential adverse event associated with placement of this device.Worsened claudication and rest pain are also listed as potential adverse events in the packaging insert following the placement of this device.On review of the information provided, there is no evidence to suggest that the user did not follow the packaging insert for 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 not occurred previously with the lot number c776875.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c776875.Secondary intervention of stent placement (neither ptx nor flex) was performed against this issue and the patient's condition was recovered.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

(b)(6) 2012 - a ziv6-35-125-6.0-120-ptx(lot#c776875) was placed in the lower part of the right sfa of a (b)(6) male patient.(b)(6) 2017 - reocclusion of the stented lesion due to thrombosis was confirmed by ultrasound imaging.Worsened intermittent claudication and rest pain were observed on the patient.(b)(6) 2017 - stent placement(neither ptx nor flex) was performed against this issue and the patient's condition was recovered.

• 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: 7094760
• MDR Text Key: 94092479
• Report Number: 3001845648-2017-00583
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140504(10)C776875
• Combination Product (y/n): N
• 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
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/09/2017
• Date Device Manufactured: 06/14/2012
• 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