MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number UNKNOWN

Device Problems Fracture (1260); Structural Problem (2506)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 10/20/2013

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Tien-yu wu et al 2013-"comparison of immediate and 2-year outcomes between excimer laser-assisted angioplasty with spot stent and primary stenting in intermediate to long femoropopliteal disease".Self-expanding nitinol stents were implanted in group b either by direct stenting or with predilatation of undersized balloon.One centimeter of overlap was employed when multiple stents were required to cover the treated arterial segments.Various types of self-expanding nitinol stents including zilver and zilver flex (25) were used during the evi at the discretion of the operators.The rates of stent fracture were also not different between the 2 groups either at 12 or 24months.

Manufacturer Narrative

Pma/510(k) # p050017/s006.Device evaluation: the unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation ¿ n/a.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zfv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that stent strut fracture is listed as a known potential adverse event within the instructions for use ifu0058-4.There is no evidence to suggest the user did not follow the ifu.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy and/or stent fatigue.Difficult patient anatomy and/or location of the stent in the body may have placed excessive force on the stent contributing to stent fatigue resulting in stent fracture.It is possible that the stent coursed under a ligament in the anatomy or was placed at a joint (e.G.Knee joint or hip joint) contributing to stress and fatigue from joint flexion/movement.Summary: the complaint is confirmed based on customer testimony.Patient outcome is unknown however, clinical input suggests that the stent fractures would likely have required a form of intervention.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10248359
• MDR Text Key: 205024752
• Report Number: 3001845648-2020-00414
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2013
• Event Location: Hospital
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male