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

Catalog Number	ZISV6-35-125-6-40-PTX
Medical Device Problem Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Pma/510(k) # p100022/s014.The zisv6-35-125-6-40-ptx stent of lot number c1219275 was implanted in the patient, and 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 on the (b)(6) 2017.Upon review of the sample label attached to the work order (c1219275), the expiry date of the device was confirmed to be ¿2017-02-22¿.This confirms that the complaint device was used after its expiry date.The customer complaint can be confirmed as the device was used after its expiry date.It can be noted that all zisv6 (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.It can be noted that the product ifu states the following: ¿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 c1219275.According to the initial reporter, there have been no adverse events reported for the patient as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
Rep stock of stents were left at the facility for a procedure.At this time, none of the stents were expired.The rep could not attend the procedure.One of the stents expired before the procedure occurred and was used for the procedure.The nurse did not realize that the product was expired.It was implanted successfully.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6435609
• Report Number: 3001845648-2017-00108
• Device Sequence Number: 18846699
• Product Code: NIU
• UDI-Device Identifier: 10827002384634
• UDI-Public: (01)10827002384634(17)170222(10)C1219275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-40-PTX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1