ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
Received Jul 7, 2026 · Event occurred Aug 14, 2025
Report 1649833-2026-00022 · MDR key 25736868
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cardiac Arrest
- Respiratory Failure
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
DESCRIPTION SUMMARY: ACCORDING TO PUBLICLY AVAILABLE INFORMATION, A PEDIATRIC PATIENT UNDERWENT HEART VALVE REPLACEMENT SURGERY. FOLLOWING THE PROCEDURE, THE PATIENT REPORTEDLY EXPERIENCED SIGNIFICANT POSTOPERATIVE COMPLICATIONS REQUIRING PROLONGED MECHANICAL CIRCULATORY AND RESPIRATORY SUPPORT. THE PATIENT'S FAMILY SUBSEQUENTLY SOUGHT EVALUATION AT ANOTHER MEDICAL CENTER, WHERE CONCERNS WERE REPORTEDLY RAISED REGARDING THE ORIENTATION OF THE IMPLANTED HEART VALVE. CORRECTIVE INTERVENTION WAS SUBSEQUENTLY PERFORMED. ADDITIONAL INFORMATION WILL BE REQUESTED AS IT BECOMES AVAILABLE. DEVICE PROBLEM SUMMARY: THE REPORTED DEVICE-RELATED ISSUE INVOLVES AN ALLEGATION THAT THE IMPLANTED HEART VALVE MAY HAVE BEEN POSITIONED IN AN INCORRECT ORIENTATION DURING IMPLANTATION, RESULTING IN IMPAIRED VALVE FUNCTION AND THE NEED FOR ADDITIONAL MEDICAL EVALUATION AND CORRECTIVE INTERVENTION. BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO SPECIFIC DEVICE MALFUNCTION HAS BEEN IDENTIFIED, AND THE ROLE OF THE DEVICE VERSUS THE IMPLANTATION PROCEDURE HAS NOT BEEN ESTABLISHED. PATIENT IMPACT SUMMARY: THE PATIENT REPORTEDLY EXPERIENCED SERIOUS POSTOPERATIVE COMPLICATIONS FOLLOWING HEART VALVE REPLACEMENT SURGERY, INCLUDING THE NEED FOR PROLONGED LIFE-SUSTAINING SUPPORT AND SUBSEQUENT REINTERVENTION. ACCORDING TO PUBLICLY AVAILABLE REPORTS, THE PATIENT LATER UNDERWENT CORRECTIVE TREATMENT AT ANOTHER MEDICAL CENTER AND REPORTEDLY DEMONSTRATED CLINICAL IMPROVEMENT THEREAFTER. THIS INVESTIGATION IS RELEGATED TO ONXACE-25 SERIAL NUMBER (B)(6) (2026), WITH AN ALLEGATION OF IMPROPER VALVE ORIENTATION FOLLOWING IMPLANTATION.