Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study

Purpose: Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement. Materials and methods: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses. Results: Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]). Conclusions: While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.