Acute Clinical Adverse Outcomes Associated With the Cor-Knot

Area of Science:

• Cardiovascular Surgery
• Medical Device Safety

Background:

• Manual knot tying in cardiac valve operations is associated with increased operative times and costs.
• The Cor-Knot device offers an alternative using an automatic titanium fastener system.
• Adverse outcomes associated with the Cor-Knot device have not been previously characterized.

Purpose of the Study:

• To characterize adverse events associated with the Cor-Knot device.
• To identify the types and frequencies of complications related to Cor-Knot usage.
• To analyze factors contributing to adverse incidents involving the Cor-Knot.

Main Methods:

• A nationally representative cohort of adverse events from 2015-2023 was analyzed using the Manufacturer and User Facility Device Experience database.
• Reports were screened to identify incident types and complications.
• Device and patient complications were categorized and reported as proportions.

Main Results:

• An increasing trend in reported adverse events was observed from 2015 to 2023.
• Malfunction (63.5%) was the most frequent device incident, often due to misfire or usage issues.
• Patient complications included valve insufficiency (10.8%), foreign body presence (8.1%), and hemorrhage (2.7%).

Conclusions:

• Malfunction, particularly misfire and usage issues, is a primary concern with the Cor-Knot device.
• Patient complications such as valve insufficiency, foreign body presence, and hemorrhage require attention.
• Enhanced device training is crucial to minimize adverse events as Cor-Knot utilization grows.