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

Catalog Number ZISV6-35-125-7-100-PTX

Device Problem Device Expiration Issue (1216)

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

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001.The zisv6-35-125-7-100-ptx stent of lot number c1223629 was implanted in the patient, and not returned for evaluation.With the information provided a document based investigation was conducted.According to information provided, an expired zilver ptx stent was implanted in the patient on (b)(6) 2017.Upon review of the sample label attached to the work order (c1223629), the expiry date of the device was confirmed to be ¿2017-03-16¿.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 c1223629.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 Description

Expired stent was placed.Procedure went well and as intended.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6559642
• MDR Text Key: 74909733
• Report Number: 3001845648-2017-00169
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)170316(10)C1223629
• 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: Other
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-100-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: 04/14/2017
• Event Location: Hospital
• Date Manufacturer Received: 04/14/2017
• Date Device Manufactured: 04/18/2016
• 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: 70 YR