The First 4 Years of Postmarketing Safety Surveillance Related to the MitraClip Device: A United States Food and Drug Administration MAUDE Experience.

CONCLUSIONS: While injuries reported to the FDA have steadily increased with more widespread use of TMVR, device- or procedure-related death reports have accrued more slowly, corroborating a potential institutional or operator learning curve with this device. However, in light of incomplete and poor data quality, higher-fidelity systems of postmarketing safety surveillance are needed in the evaluation of emerging devices. PMID: 32269176 [PubMed - as supplied by publisher]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research