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

Catalog Number ZISV6-35-125-7-120-PTX

Device Problem Delivery System Failure (2905)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

Problem statement "the zilver ptx was deployed distal sfa.Midway through deployment, the deployment system broke.The thumbwheel failed to retract the retraction sheath.At this point the physician was able to wiggle the system back and forth enabling deployment; however, this stretched the stent.The procedure was completed successfully." device evaluation the zisv6-35-125-7-120-ptx device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, the physician felt that the stretching of the stent could have an impact on the long term durability and patency of the stent.The device was advanced over an unknown wire guide, and it is unknown if the device was flushed prior to use.The stent was fully deployed.The patient¿s anatomy was not severely calcified or tortuous.Pre-dilation was conducted prior to stent deployment.The entire stent deployed in the patient, but was stretched as a result of the difficulties during deployment.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible root causes for this occurrence could include the device encountering resistance during deployment.Such resistance could cause or contribute to the malfunction of the thumbwheel mechanism and the inability to deploy the stent.The stent was likely stretched as the physician completed deployment by wiggling the device.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.There is no evidence to suggest that the customer did not follow the instructions for use.Document review as the lot number of the complaint device is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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 stent was fully deployed.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¿ and ¿retraction wire separates from stent retraction sheath'.The zilver ptx was deployed distal sfa.Midway through deployment, the deployment system broke.The thumbwheel failed to retract the retraction sheath.At this point the physician was able to wiggle the system back and forth enabling deployment; however, this stretched the stent.The procedure was completed 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: 7333915
• MDR Text Key: 102741363
• Report Number: 3001845648-2018-00120
• Device Sequence Number: 1
• Product Code: NIU
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-120-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: 02/13/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2018
• 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