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

Catalog Number ZIV6-35-125-7-100-PTX

Device Problem Device Expiration Issue (1216)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

An expired zilver stent was implanted in a patient.The customer has experienced no adverse effects.

Manufacturer Narrative

The ziv6-35-125-7-100-ptx stent of lot number c1176324 was not returned for evaluation.With the information provided a document based investigation was carried out.According to information provided, an expired zilver ptx stent was implanted in the patient.Upon review of the sample label attached to the work order ((b)(4)), the expiry date of the device was confirmed to be ¿2016-08-19¿.However, the date of implantation was not provided.This information has been requested.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 all zilver ptx devices are shipped with a product label placed on the outer zilver ptx carton box and product label placed on the inner pouch.Both labels contain information with manufacturing and expiration dates.Based on the above, the most likely cause of this complaint can be attributed to customer error as zilver ptx devices should not be used beyond the date specified on the product label.In addition, the following is stated in the instructions for use provided with each ptx device: ¿do not use the stent after the ¿use by¿ date specified on the package¿.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 this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1176324.According to the initial reporter, the patient was informed about the expired device.As of 10 oct 2016 there have been no adverse events reported for the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted with the investigation conclusions.An expired zilver stent was implanted in a patient.The customer has experienced no adverse effects.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6019832
• MDR Text Key: 57098198
• Report Number: 3001845648-2016-00292
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002249377
• UDI-Public: (01)10827002249377(17)160819(10)C1176324
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7-100-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/07/2016
• Date Device Manufactured: 11/24/2015
• 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