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

Model Number G38482

Device Problems Kinked (1339); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001.Problem statement: as reported to customer relations, "the zilver ptx was inserted thru a 6fr sheath (unknown make and model).During insertion, the stent encountered increased resistance at which point, upon significant resistance the physician chose to remove and inspect the stent.Upon removal and inspection, it was noted the stent was accordioned.Approximately 10 cm of the stent was accordioned.At this point, the facility called the regional manager for support / advice on how to proceed.Its unknown at this time how the procedure was completed." device evaluation: the zisv6-35-125-6-120-ptx device involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From the sales representative¿s testimony, it is known that the procedure was completed with a competitor¿s device, and the complaint device was discarded.The complaint device was advanced over a 0.035¿ diameter, cook amplatz wire guide.The device was flushed prior to use.The stent was not deployed.The patient¿s anatomy was calcified and tortuous.Pre-dilation was conducted prior to stent deployment.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 and tortuous anatomy.The difficult anatomy could have created resistance during advancement, causing or contributing to the inability to advance the device to the target location.The anatomy could have also damaged the distal end of the device, causing the stent to accordion.However, as the device has not been 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 instructions for use: "if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device." 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.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Initial mdr is being submitted based on the device malfunction precedence.As reported to customer relations, "the zilver ptx was inserted thru a 6fr sheath (unknown make and model).During insertion, the stent encountered increased resistance at which point, upon significant resistance the physician chose to remove and inspect the stent.Upon removal and inspection, it was noted the stent was accordioned.Approximately 10 cm of the stent was accordioned.At this point, the facility called the regional manager for support / advice on how to proceed.Its unknown at this time how the procedure was completed.".

• 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: 7361121
• MDR Text Key: 103526543
• Report Number: 3001845648-2018-00141
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)190816(10)C1403293
• 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: Physician
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/23/2018
• Date Device Manufactured: 09/22/2017
• 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