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Updated: May 11, 2026
Murine Model of Central Venous Stenosis using Aortocaval Fistula with an Outflow Stenosis
Published on: July 11, 2019
A single-center experience with luminal venous cannulae obstruction caused by clot formation during bypass
Gregory S Matte1, Robert J Howe, Frank Pigula
1Department of Cardiac Surgery, Boston Children's Hospital, Boston, Massachusetts 02115, USA. gregory.matte@cardio.chboston.org
Insights
Venous cannula clot formation during bypass surgery was identified. Post-bypass inspection and reporting protocols are recommended to prevent these serious adverse events.
Area of Science:
- Cardiovascular Surgery
- Medical Device Safety
Background:
- Two bypass cases in 2011 showed poor venous return and luminal clot formation in venous cannulae.
- These events were reported to the Food and Drug Administration (FDA) via the Non-Routine Event Reporting Program.
Purpose of the Study:
- To investigate the incidence and causes of luminal clot formation in venous cannulae during cardiopulmonary bypass.
- To implement and evaluate a surveillance protocol for identifying and managing cannula-related clotting events.
Main Methods:
- Institution-wide inspection of all venous cannulae post-bypass initiated in December 2011.
- A 9-month surveillance period documented 33 instances of luminal clot formation in 21 patients.
- Manufacturer production changes and subsequent cannulae batches were analyzed.
Main Results:
- During surveillance, 33 venous cannulae (in 21 patients) showed luminal clot formation; only one required change-out.
- Manufacturer identified production changes as the likely cause of clotting.
- New cannulae produced after September 2012 showed a significant reduction in clotting events.
Conclusions:
- Post-bypass inspection of venous cannulae is crucial for identifying luminal clot formation.
- Internal, manufacturer, and FDA reporting systems are vital for addressing device-related safety issues.
- Collaborative efforts with manufacturers are essential for improving medical device safety and patient outcomes.
Abstract:
Our institution experienced two bypass cases from January through December 2011 in which venous return was significantly variable and at times poor. Luminal clot formation in the venous cannulae was found in each case postbypass. These events were captured and monitored through our institution's Non-Routine Event Reporting Program and eventually reported to the Food and Drug Administration (FDA). We began inspecting all venous cannulae postbypass in December 2011. During a subsequent 9-month surveillance period, we documented 33 venous cannulae in 21 patients with luminal clot formation. Only one cannula during this surveillance period required change-out on bypass. The manufacturer eventually identified changes in production that likely caused the clotting events. The manufacturer modified their production methods and began supplying cannulae produced under the new method in September 2012. We have experienced only one clotting event with the new cannulae and in that instance, the metal tip was found to be defective. We recommend inspection of all venous cannulae postbypass with internal, manufacturer, and FDA reporting for those noted to have luminal clot formation.
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