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

Catalog Number ZISV6-35-125-6-60-PTX

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s014.(b)(4).The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

The facility was getting ready for a procedure.However, the product packaging was received open and not sealed.The facility didn't want to use this device as its sterility was compromised.".

Manufacturer Narrative

Pma/510(k) # p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).This follow up report is being submitted due to the update of the investigation into this event and the conclusion of this investigation.The zisv6-35-125-6-60-ptx device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it was noted that the inner tyvek pouch was found ripped after the customer opened the outer foil pouch.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the handling of the device as the device packaging was opened, with the customer not moving the inner packaging away from the tear notches of the foil pouch.However, as the device was not returned for evaluation, the lot code is not known and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.There is no evidence to suggest that the customer did not follow the recommendations in the product instructions for use.As the lot number of the complaint device is 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 packaging integrity.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred prior to patient contact, and the device was not used.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the update of the investigation into this event and the conclusion of this investigation.Initial report details: the facility was getting ready for a procedure.However, the product packaging was received open and not sealed.The facility didn't want to use this device as its sterility was compromised.".

• 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: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6900241
• MDR Text Key: 88403829
• Report Number: 3001845648-2017-00415
• 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,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-60-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: 08/30/2017
• Event Location: Hospital
• Date Manufacturer Received: 08/30/2017
• 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