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

Catalog Number ZIV6-35-80-5.0-100-PTX

Device Problem Device Expiration Issue (1216)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: p100022/s001.The ziv6-35-80-5.0-100-ptx stent of lot number c1011016 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 (c1011016), the expiry date was confirmed to be ¿2016-04¿.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 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.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.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The stent was correctly placed on the culprit lesion 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 Description

Zilver ptx device with lot number c1011016 x1 was placed in patient but was expired.Nurse took the stent on the shelves and gave it to dr as required.Stent was implanted, with very good result.Procedure ended with no complication.It was the last patient of the day and the cook rep stayed in the facility in order to perform a consignment check when it was no disturbance for the surgical team.The rep noted the stent used had expired a month before.

• 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: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5696974
• MDR Text Key: 46494749
• Report Number: 3001845648-2016-00145
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002552873
• UDI-Public: (01)10827002552873(17)160417(10)C1011016
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-80-5.0-100-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: 05/11/2016
• Event Location: Hospital
• Date Manufacturer Received: 05/13/2016
• Date Device Manufactured: 06/16/2014
• 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