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

Model Number	G38481
Medical Device Problem Codes	Fracture (1260); Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma #p100022/s014.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.Problem statement: as reported to customer relations, "the stent stopped deploying and half of the stent remains inside the patient.The deployment system was pulled out." device evaluation: the zisv6-35-125-6-100-ptx device 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 complaint device was advanced over a boston scientific control wire (bsci v-18) of 0.018¿ diameter.The device was flushed prior to use.The stent was partially deployed and fractured.The patient anatomy was calcified.Pre-dilation was conducted prior to stent deployment.The physician confirmed that there was no intervention conducted to treat the fractured stent portion.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 calcified patient anatomy, or the use of a non-recommended wire guide.From customer testimony, the patient anatomy was calcified, and the device was advanced over a 0.018¿ diameter wire guide.The difficult anatomy could have created resistance during deployment, and the wire guide could have provided insufficient support during deployment.These factors could have causes or contributed to the deployment mechanism malfunction and the stent partially deploying.However, as the device was not returned and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that as per the product instruction for use: precautions: ¿a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system¿ document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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 this lot number.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk was determined to be low (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.There was no intervention conducted to treat the partially deployed stent.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture" and "deployment issue resulting in exposed stent removed from patient with the delivery system".As reported to customer relations, "the stent stopped deploying and half of the stent remains inside the patient.The deployment system was pulled out".

• 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: 7663542
• Report Number: 3001845648-2018-00304
• Device Sequence Number: 19272040
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)190912(10)C1426421
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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 Expiration Date: 09/12/2019
• Device Model Number: G38481
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: C1426421
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1