Background: Implantable Dopplers (IDs) are widely used for postoperative free flap vascular monitoring. However, IDs may contribute to free flap complications or failure and better understanding of device malfunctions is needed.
Methods: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for all reports of ID adverse events from two leading manufacturers (Cook Vascular and Synovis Life Technologies) in free flap surgery from January 2010 to March 2020. Reports were reviewed and categorized. A comparison of reoperations within select categories was performed using Chi-square analysis.
Results: Of 209 included reports, the most common device malfunctions were venous anastomotic coupler misalignment (35.4%) and coupler ring detachment (24.4%). Synovis devices were used in 100% of reports of vessel compression and Cook Vascular devices were used in 77.7% of reports of probe detachment. Of 74 patient-related adverse events, the most common were reoperation (47.3%) and vessel occlusion (28.4%). Of five reported events of flap failure, two were associated with loss of ID signal. The proportion of Doppler signal loss events leading to reoperation was significantly greater than the proportion of any other Doppler-related event leading to reoperation. Intraoperative coupler replacement was the most commonly reported intervention (n = 86), and venous anastomosis with hand-suturing occurred in 30 device malfunctions.
Conclusion: This study demonstrates a variety of ID-related malfunctions. One-third of device malfunctions were associated with patient complications, and false-positive Doppler signal loss contributed substantially to the requirement of surgical re-exploration. These are important considerations for surgical teams utilizing IDs in free tissue transfer procedures.
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