ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER
Received Jun 30, 2026 · Event occurred Sep 10, 2017
Report 1649833-2026-00020 · MDR key 25667364
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Heart Block
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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
Description of Event or Problem
ACCORDING TO THE INITIAL REPORT RECEIVED ON (B)(6) 2026, A PATIENT IN THE ON-X PAS STUDY EXPERIENCED COMPLETE HEART BLOCK. THE EVENT START DATE WAS 10SEP2017 WITH A REPORTED DURATION OF 2 HOURS. TREATMENT: SURGERY. REPORTED AS FULLY RESOLVED. THE ON-X DEVICE WAS IMPLANTED ON (B)(6) 2017. INFORMATION REGARDING ETIOLOGY OF THE EVENT PENDING.