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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ziv6-35-125-6-80-ptx device of lot number c1194627 was returned to cirl.It was returned in the original packaging and was open on receipt.On evaluation of the returned device, it was confirmed that the red safety tab was still in place, indicating that deployment had not been attempted.The stent was exiting the flexor by 2mm, confirming the complaint information.Using a calibrated ruler, the outer sheath measured 125.8cm and was confirmed to be in spec.The entire device was visually examined for damage; no damage was noted.Using a syringe of water, the device was flushed through both flushing ports with no issues.The device was advanced over a 0.035¿¿ wire guide with no issues noted.The stent was deployed with no difficulties.There was no damage to the stent.The customer complaint can be confirmed as the stent was partially deployed with the red safety tab in place.Upon examination of the returned device, there was no evidence to suggest that the device was manufactured incorrectly.It is possible that the sheath could have compressed during advancement of the delivery system, resulting in the stent being partially deployed.This could have occurred if the patient anatomy was severely calcified or tortuous.It can be noted that information regarding calcification/tortuosity was requested, however no information could be provided.As the conditions of use could not be replicated in the laboratory setting, a definitive root cause of this occurrence cannot be determined.It may be noted that a project has been completed to improve the performance of the sheath and overall deployment of the device.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.According to the initial reporter, the device was removed and another device was used to successfully complete the procedure.No adverse effects were experienced by the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
They were not at the target lesion yet.The physician noticed on fluro that the zilver ptx stent was partially exposed outside of the sheath.They removed the device and successfully completed the procedure with another device.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5626935
• Report Number: 3001845648-2016-00117
• Device Sequence Number: 16279290
• Product Code: NIU
• UDI-Device Identifier: 10827002248905
• UDI-Public: (01)10827002248905(17)161120(10)C1194627
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZIV6-35-125-6-80-PTX
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2016
• Initial Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1