Among 43,239 FDA MAUDE safety reports spanning a decade (2016–2026), 376 unplanned emergency open-heart surgeries during or immediately after transcatheter aortic valve replacement (TAVR) were identified. Documented mortality reached 40.9% (104 of 254 cases with known outcomes). Ventricular perforation or laceration carried 74.1% mortality (OR 4.86; 95% CI 1.97–11.99), while valve embolization, migration, or malposition was the most frequent trigger (32.4% of events). Crucially, valve explantation with surgical AVR was associated with significantly lower mortality (18.9%; OR 0.29), suggesting that definitive surgical correction outperforms piecemeal interventions.
TAVR has transformed aortic stenosis treatment, expanding eligibility across all surgical risk tiers — yet catastrophic procedural failure remains a low-frequency, high-stakes reality. These findings, drawn from passive post-marketing surveillance rather than a prospective registry, carry inherent limitations: MAUDE reports are voluntary, subject to inconsistent detail, and cannot establish incidence rates or capture unreported events. Survivor bias and incomplete outcome documentation further temper interpretation. Still, the granular complication-to-mortality mapping here — particularly the fourfold mortality spike with ventricular injury — has direct implications for procedural team preparedness, hybrid operating room infrastructure, and surgical backup protocols. The platform-specific differences in complication patterns, though exploratory, warrant prospective validation. As a preprint not yet peer-reviewed, these results may shift with formal scrutiny. Provisionally, this work is confirmatory in framing TAVR bailout mortality but incrementally advances mechanistic specificity beyond existing registries.