MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

This event has been reported by the manufacturer under mdr#3001845648-2019-00544.

Event Description

Jeon-slaughter.This study conducted a comparative effectiveness analysis of zilver ptx and contemporary bms for femoropopliteal artery endovascular intervention using the multicenter excellence in peripheral artery disease (xlpad) this study compared clinically driven 1-year target-lesion revascularization (tlr), target-vessel revascularization (tvr), and target-limb revascularization rates between zilver ptx stent and bms treatments in femoropopliteal distribution.They also compared 1-year all-cause mortality in the respective treatment groups.The study extracted data from the available 969 xlpad registry patients who underwent femoropopliteal stent interventions (unmatched data) between october 2013 and december 2016 at eleven xlpad participating sites in the united states.One-year all-cause mortality and three revascularization outcomes ¿ clinically driven tlr, tvr, and target-limb revascularization ¿ were included in the analysis.174 zilver ptxs and 174 bmss were used in this study.The bms group contained 53 zilver bare metal stents.This file will address two patients who underwent multiple interventions in the zilver ptx group(two or more).

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 9323184
• MDR Text Key: 185761825
• Report Number: 3005580113-2019-00753
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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?: Yes
• Distributor Facility Aware Date: 11/11/2019
• Event Location: Hospital
• 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