(0680) Microvascular Anastomotic Coupler: A Comprehensive MAUDE Database Analysis

Introduction: While microvascular anastomotic couplers are generally deemed safe and widely utilized by microvascular and reconstructive surgeons, the complication profile associated with this device has not been thoroughly delineated. The goal of this study is to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database for a thorough examination of adverse events (AE) linked to the utilization of microvascular anastomotic couplers. Reports were individually tabulated and events were categorized with special attention to AEs and patients outcomes.

Methods: The FDA MAUDE database was queried for all medical device reports (MDR) related to microvascular anastomotic coupler devices from January 2013 to October 2023.

Results: There were 302 reported instances of device malfunction, with 20 (6.6%) events resulting in patient injury, 15 (3%) events leading to thrombosis, 9 (3%) causing tissue damage, and 5 (1.6%) resulting in blood vessel perforation. The most commonly encountered malfunctions by surgeons were devices operating differently than expected (71 cases or 23.6%), disconnection (37 cases or 12.3%), material twisting/bending (26 cases or 8.6%), and loose or intermittent connection (24 cases or 8%). Importantly, none of the reported malfunctions resulted in death or serious injury.

Conclusions: While the use of microvascular anastomotic couplers in microvascular surgeries is generally considered a safe procedure, there have been several reported adverse events (AEs). Enhancing awareness of associated complications can aid in more effectively counseling patients during the informed consent process and guide providers in their clinical decision-making.