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

Catalog Number UNKNOWN

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001.The device was implanted in the patient and is therefore unavailable for investigation.With the information provided a document based investigation was carried out.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It may be noted however 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.As there is no device returning for evaluation, a definite root cause of this event cannot be determined.As per the instructions for use, it states "do not use the stent after the "used by" date specified on the package." as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.There was no surgical intervention reported as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for any potential emerging trends.

Event Description

As reported to customer relations, "the facility used and implanted and expired zilver ptx (pin and pull).".

• Brand Name: UNKNOWN
• 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: 6596502
• MDR Text Key: 76193743
• Report Number: 3001845648-2017-00199
• Device Sequence Number: 1
• Product Code: NIU
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2017
• Event Location: Hospital
• Date Manufacturer Received: 05/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1