Adverse events after transcatheter edge-to-edge repair: descriptive post-marketing surveillance analysis of MitraClip and PASCALTM from the Manufacturer and User Facility Device Experience (MAUDE) registry
Ananya Kommuri, Adwoa Boatemaah Adu-Sarkodee, Sheriff N. Dodoo · 2026
Read Adverse events after transcatheter edge-to-edge repair: descriptive post-marketing surveillance analysis of MitraClip and PASCALTM from the Manufacturer and User Facility Device Experience (MAUDE) registry by Ananya Kommuri, Adwoa Boatemaah Adu-Sarkodee, Sheriff N. Dodoo (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/PMC13358508.txt.
Description
Ananya Kommuri and co-authors present a 2026 study of safety reports for two heart valve repair devices. MitraClip and PASCAL fix a leaky mitral valve through a tube in a blood vessel, with no open-heart surgery. The team mined a United States database of device problem reports to compare the two.
From 2022 to 2025 they gathered 518 reports and sorted the problems into 13 types. Device parts breaking or coming loose were the most common reports. Real-world reports like these cannot prove which device is safer, but they show regulators and doctors which faults to watch for as use of these devices grows.
Catalog record
| CREATOR | Ananya Kommuri, Adwoa Boatemaah Adu-Sarkodee, Sheriff N. Dodoo |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 25541 |
| LICENSE | https://creativecommons.org/licenses/by/4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |