ONX AORTIC ANATOMIC EXT 23
Received Jun 25, 2026 · Event occurred Mar 28, 2018
Report 1649833-2026-00019 · MDR key 25619402
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Aortic Valve Insufficiency/ Regurgitation
Narrative
Additional Manufacturer Narrative
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
Description of Event or Problem
ACCORDING TO THE INITIAL NOTIFICATION THIS IS A PATIENT IN THE ON-X PAS STUDY AND THE PATIENT EXPERIENCED AN EVENT ON (B)(6) 2018 THAT WAS REPORTED BY THE SITE ON 04JUN2026. THE EVENT REPORTED WAS AS PROSTHETIC VALVE DYSFUNCTION, SPECIFICALLY PARAVALVULAR LEAK. THE EVENT IS ONGOING. THIS EVENT IS RELEGATED TO ONXANE-23 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF PROSTHETIC VALVE DYSFUNCTION RESULTING IN PARAVALVULAR LEAK.