Adverse Events of Tracheobronchial Stents: A MAUDE Database Study With Focus on Metallic Stents

Tracheobronchial stents treat conditions that reduce airflow such as malignancy, tracheomalacia, and stenosis, but may fail and cause complications. This study aims to use the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to understand adverse events related to tracheobronchial stent use to reduce future complications.

The MAUDE database was searched for "Prosthesis, Tracheal, Expandable," "Prosthesis, Tracheal, Expandable, Polymeric," and "Prosthesis, Tracheal, Preformed/Molded" from January 2014 to December 2023. Reports were analyzed and complications were categorized.

We identified 525 reports. 405 (77.1%) reports listed indications including airway stenosis (n = 312, 51.0%), malignancy-related airway stricture (n = 258, 42.2%), tracheoesophageal fistula (n = 26, 4.2%), and tracheobronchomalacia (n = 16, 2.6%). A total of 768 different adverse events were cataloged. The most common device-related complication was stent deployment failure (N = 236, 30.7%). 94 patient injuries occurred; the most common patient injury was airway occlusion/collapse (n = 26, 28.6%), followed by airway bleeding/exsanguination (N = 12, 13.6%), and intubation/ICU care (N = 11, 12.5%). Six cases led to death (0.7%). Stents placed due to tracheobronchomalacia had more cases of airway occlusion/collapse, pneumonia, and intubation/ICU care than all other indications (all p < 0.05).

Most adverse events were related to technical failure while severe complications such as airway obstruction were few, and mortality was rare. These risks are important to note when utilizing tracheobronchial stents.

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