MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number	ZIV6-35-125-7-40
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The ziv6-35-125-7-40 stent of lot number c877174 was implanted and was not returned for evaluation.With the information provided a document based investigation was carried out.According to information provided, the date of the event was the (b)(6) 2016.Upon review of the sample label attached to the work order, the expiry date was confirmed to be ¿2016-04¿.This confirms that the complaint device was used after its expiry date.In addition, the customer confirmed that the product was noted as expired after implantation.The customer complaint can be confirmed as the device was used after its expiry date.It can be noted that all zilver devices are shipped with a product label placed on the outer zilver 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 devices should not be used beyond the date specified on the product label.The product ifu states that the stent system is to be used prior to the expiration date specified on the package.Prior to distribution all zilver devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Instruction.Upon review of the sample label attached to the work order, it has been confirmed that the product label clearly identified the expiration date as ¿2016-04¿.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The stent was correctly placed and no retrieval was performed.The patient did not require any additional procedures.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
The stent was placed, it was then noted the stent had expired.The customer has no adverse effects.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6019831
• Report Number: 3001845648-2016-00290
• Device Sequence Number: 1420099
• Product Code: NIO
• UDI-Device Identifier: 10827002438269
• UDI-Public: (01)10827002438269(17)160425(10)C877174
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2016

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: ZIV6-35-125-7-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1