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 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

The ziv6-35-125-6-80-ptx device of lot number c1092396 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 on the (b)(6) 2016; approximately one month passed its expiration date, 27 jan 2016.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.The complaint is confirmed as the device was used after the specified expiration date.The following is also 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¿.The root cause of this occurrence can be attributed to human error.According to information provided, the rep mistakenly providing an expired device, however the expiry date was also not noted by the end user at the hospital.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 the sample label attached to the work order, it has been confirmed that the product label clearly identified the expiration date as ¿2016-01-27¿.According to information provided, no adverse effects were experienced by the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Area representative mistakenly provided expired device; device implanted in patient with no complications.

• 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: 5523039
• MDR Text Key: 41060487
• Report Number: 3001845648-2016-00076
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)160127(10)C1092396
• 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
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/29/2016
• Event Location: Hospital
• Date Manufacturer Received: 03/01/2016
• Date Device Manufactured: 03/16/2015
• 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