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

Model Number G38482

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

Problem statement: as reported to customer relations: "put stent in, started to deploy it, the wheel stopped working when physician was rolling it back.After wheel stopped working, was also getting stuck on wire.Physician went back with bigger sheath and used another device successfully." device evaluation: the zisv6-35-125-6-120-ptx device involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to request to arrange return of the complaint device.The investigation will be updated once the device as been provided and evaluated.The customer stated that the device was initially used with a terumo access sheath.The device was advanced over a contralateral approach.The target location for the device was the superficial femoral artery (sfa).From customer testimony, it is known that the complaint device was advanced over a 0.014¿ diameter, non-hydrophilic viper wire guide.The device was flushed prior to use.The patient¿s anatomy was not severely calcified or tortuous.The stent slightly deployed, but no portion of the device remained in the patient.Pre-dilation was no 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 use of a non-recommended wire guide.From customer testimony, the complaint device was advanced and deployed over a 0.014¿ diameter wire guide.The wire guide could have offered insufficient support during deployment, which could have caused or contributed to the inability to deploy the stent fully.However, as the information and device have not yet been provided, 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.It may be noted that the temporary failure mode ¿difficult deployment ¿ user error¿ has been assigned, pending device return and evaluation.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk will be assessed for this complaint when the device is returned and evaluation, and once completed the investigation will be updated with the risk details.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: ¿thumbwheel malfunctions during deployment".As reported to customer relations: "put stent in, started to deploy it, the wheel stopped working when physician was rolling it back.After wheel stopped working, was also getting stuck on wire.Physician went back with bigger sheath and used another device successfully.".

• 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: 7391791
• MDR Text Key: 104533351
• Report Number: 3001845648-2018-00153
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)191107(10)C1448228
• 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: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/06/2018
• Date Device Manufactured: 01/30/2018
• 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