ONX MITRAL CONFORM 25/33
Received Jun 24, 2026 · Event occurred Mar 25, 2026
Report 1649833-2026-00018 · MDR key 25615902
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
41 YR · Male
- Mitral 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 REPORT RECEIVED A MITRAL IRC (IMPLANT REGISTRATION CARD) FOR A PATIENT WITH EXISTING MITRAL IMPLANT. ADDITIONAL INFORMATION FROM THE ARTIVION REPRESENTATIVE: I SPOKE TO SURGEON. HE IS CONFIDENT THE VALVE THAT WAS EXPLANTED WAS FUNCTIONAL. HE EXAMINED THE VALVE UPON EXPLANT AND THE LEAFLETS MOVED FREELY AS DESIGNED. HE BELIEVES THAT THE INITIAL IMPLANTING SURGEON DID NOT FULLY EXCISE THE NATIVE VALVE LEAFLETS CAUSING PANNUS AND THUS RESTRICTING FULL LEAFLET OPENING OF THE ON-X VALVE. I AM UNABLE TO RETRIEVE OP NOTES. EXPLANTING SURGEON INDICATED THAT THE PATIENT HAD A SUBOPTIMAL INITIAL SURGERY WITH MULTIPLE COMORBIDITIES LENDING TO THE VALVE NEEDING EXPLANTED. EXPLANTED VALVE WAS DISCARDED. PATIENT IS DOING WELL POST OPERATIVELY. THIS INVESTIGATION IS RELEGATED TO ONXMC-25/33 SERIAL NUMBER (B)(6) WITH ALLEGATION OF EXPLANT.