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

Model Number	G38486
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 pma/510(k) #p100022/s014 the zisv6-35-125-7-40-ptx device of lot number c1333679 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that the device was advanced either over a cook rosen wire guide, of 0.035¿ diameter or a cook amplatz wire guide, of 0.035¿ diameter.The wire guides were non hydrophilic, and there was no damage noted on the wire guide.The exterior portion of the wire guide was wiped.The device was flushed prior to use, and the physician reported that the hub may have cracked.The patients anatomy was calcified and tortuous, but other devices had no difficulty advancing over the aortic bifurcation.The procedure was 5 to 10 minutes from passing the device into the body until the attempted removal.The wire guide was advanced over a crossing catheter prior to advancing the complaint device.There is no evidence to suggest this event did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the patient anatomy.The customer reported that the patient had a calcified and tortuous anatomy.The anatomy could have applied high forces to the device.In addition, the customer reported that the flushing port may have cracked during flushing.A damaged flushing port may have created resistance when passing the wire guide through the device.These factors may have caused or contributed to the difficulty withdrawing the complaint device from the patient.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.As per the product instruction for use: ¿following stent deployment, if resistance in met during the withdrawal of the delivery system, carefully remove the delivery system and wire guide as a unit¿.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 c1333679.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 or Problem Description
This initial report is being submitted due to the malfunction precedence: "delivery system cannot be withdrawn".This report forms part of retrospective review of open complaints for a new malfunction precedence for this device family.Balkin sheath was up an over the aortic bifurcation, stiff.035 wire was down the contra-lateral sfa, pre-dil occurred and physician decided to place stent.Stent was difficult to track to lesion, deployed fine, and could not be removed so wire and catheter had to be removed together.

• 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: 6810634
• Report Number: 3001845648-2017-00352
• Device Sequence Number: 2065981
• Product Code: NIU
• UDI-Device Identifier: 10827002384863
• UDI-Public: (01)10827002384863(17)170923(10)C1333679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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 Model Number: G38486
• Device Catalogue Number: ZISV6-35-125-7-40-PTX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1