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

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-125-6-80-ptx device of unknown lot number was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.According to information provided, the stent was implanted 2 days past the expiry date.Additional information was requested but no information has been received to date.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.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.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¿.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.As the lot number of the complaint device is unknown, a review of the relevant documentation cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.In addition, 100% inspection is carried out on all labels.No adverse effects have been reported for this patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

User facility called in stating a 2 day expired zilver ptx stent has been implanted into a patient.

• 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: 5659713
• MDR Text Key: 45314913
• Report Number: 3001845648-2016-00128
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)160416(10)C1125249
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6-80-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: 04/18/2016
• Event Location: Hospital
• Date Manufacturer Received: 04/20/2016
• Date Device Manufactured: 06/29/2015
• 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
• Patient Age: 73 YR