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

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Mathlouthi 2020, zilver flex.Among 296 patients who underwent femoropopliteal stenting, there were no differences in the 2-year limb salvage, primary patency, primary assisted patency, and secondary patency between the paclitaxel-eluting stent (pes) and the baremetal stent groups.A retrospective review of the medical records of 296 patients who underwent fpa stenting between january 2011 and december 2017 was performed.Patients were grouped into bms and pes groups.The primary end point was all-cause mortality.Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency.A comparison between the two groups within transatlantic inter-society consensus (tasc) ii subgroups was also performed.Assisted primary patency is patency of the endovascular intervention achieved with the use of an additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred.As defined in society guidelines.This complaint is capturing 6 cases of partial occlusion requiring intervention in the bare metal stent group.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.The zilver flex 35 vascular self-expanding stent (zfv6) device of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.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 all zilver flex 35 vascular self-expanding stent devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest the user did not follow the instructions for use.A definitive root cause could not be determined from the available information.It is known the baseline characteristics included contentive heart failure, chronic kidney disease, critical limb-threatening ischemia, chronic obstructive pulmonary disease, cerebrovascular disease ischemia, chronic obstructive pulmonary disease, cerebrovascular disease, diabetes mellitus, hyperlipidaemia, hypertension and ischemic heart disease therefore a possible root cause could be attributed to the patients pre-existing conditions.It should also be noted that restenosis (occlusion) of the stented artery is listed as a potential adverse event that can occur with biliary stent placement within the instructions for use.Complaint is confirmed based on customer testimony.According to the initial reporter all patients required an additional intervention.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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
• MDR Report Key: 11527984
• MDR Text Key: 255083328
• Report Number: 3001845648-2021-00226
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/20/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 02/20/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR