The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report coronary dilatation catheters¿ evaluated the safety and performance of the trek rx, mini trek rx, traveler rx, nc trek rx, nc traveler rx, nc trek otw, trek otw, mini trek otw, and mini trek ii otw.It was reported through a pmcf report that the rx mini trek may be related to unsuccessful delivery, inflation, or deflation, residual stenosis, unsuccessful achievement of timi 3 flow, perforation, arrhythmias, ventricular fibrillation, coronary artery spasm, hypotension, hypertension, unstable angina, dissection, perforation, myocardial infarction, and arrhythmias.Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the abbott dilatation catheters met the safety and performance criteria.That they perform similarly to similar competitive devices.
|
Mean age based on c1 data.Majority gender based on c1 data.Date of event: the report data included two different methods (c1 and c2), with two different data collection date ranges.The date of occurrence is unknown and estimated as (b)(6) 2019, the earliest date reported with the earliest collection method.The udi is unknown due to the part/lot number was not provided.This is a summary report.The device is not returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional devices, adverse events, and malfunctions indicated in the pmcf report are captured under separate medwatch report numbers.Literature attachment.Article title: post market clinical follow-up evaluation report coronary dilatation catheters.
|