ABSTRACT NUMBER: ESOC2026A455 REPORTED STROKE EVENTS AFTER ROBOTIC-ASSISTED ENDOLUMINAL LUNG BIOPSY: ANALYSIS OF THE MAUDE DATABASE

Abstract

Abstract Background and aims Robotic-assisted endoluminal lung biopsy is increasingly used for diagnosing peripheral pulmonary lesions; however, rare neurological complications have been reported. This study aimed to characterize reported stroke-related adverse events associated with the Ion™ endoluminal lung biopsy system using the FDA MAUDE database. Methods A retrospective descriptive analysis was conducted using the MAUDE database, querying reports involving the Ion™ endoluminal lung biopsy system until December 2025. Case narratives were manually reviewed to identify stroke-related neurological adverse events. Reports with confirmed stroke were included, and missing data were manually retrieved when available. Results A total of 1,177 reports related to the Ion™ endoluminal lung biopsy system were identified in the MAUDE database. Among these, 56 reports described stroke or stroke-like events. After review, 43 reports with confirmed stroke were included in the analysis. Female patients comprised 66% of cases, and the mean reported age was 71 years. All included reports were classified as adverse events without an identified device or use problem. In addition to stroke, convulsion or seizure was reported in eight cases, and myocardial infarction was reported in six cases. Stroke events occurred during the procedure or within 48 hours in all but one case. All patients required hospitalization or intervention, and 11 events were fatal. Reported causes attributed events to patient-related factors rather than device malfunction. Conclusions Stroke after robotic-assisted endoluminal lung biopsy is rare but serious. Although most reports did not attribute events to device malfunction, the temporal association and severity, including mortality, highlight the need for clinical vigilance. Conflict of interest Abdullah Hamad: nothing to disclose