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

Model Number G38479

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014 the zisv6-35-125-6-60-ptx device of lot number c1308988 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.The district manager was unable to confirm the exact type of contaminant, suggesting that it was a piece of plastic.On evaluation of the returned device, it was noted that the packaging was returned with the foil and tyvek pouches opened.Particulates were seen inside the tyvek pouch, which was suggested to be cardboard.The particulates may have entered the pouch during transport or handling.A small mark was observed on the white distal tip, which likely occurred due to handling.There is no evidence to suggest this event did not occur.Therefore, the customer complaint is confirmed based on customer testimony.As the device was returned with the pouches torn open, the specific contaminant could not be confirmed.As such, and as the conditions of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure packaging integrity.A review of the relevant manufacturing records (c1308988) 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 c1308988.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Upon opening the package, a contaminant was found within the sterile packaging.The device was not used / did not make patient contact.

• 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: 6759720
• MDR Text Key: 81622668
• Report Number: 3001845648-2017-00315
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384795
• UDI-Public: (01)10827002384795(17)171003(10)C1308988
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38479
• Device Catalogue Number: ZISV6-35-125-6-60-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1