ONX AORTIC HEART VALVE CONFORM-X SEWING RING AND EXTENDED HOLDER

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 THE INITIAL REPORT RECEIVED ON 16APR2026 FROM PRODUCT TRACKING ASSOCIATE, SUZANNE PROPER, AN AORTIC IMPLANT REGISTRATION CARD (IRC) WAS RETURNED FOR A PATIENT TREATED AT (B)(6) MEDICAL CENTER. THE IRC INDICATED THAT THE DEVICE, ONXACE-21 (SERIAL NUMBER (B)(6)), WAS ¿NOT KEPT IMPLANTED THEN EXPLANTED.¿ THE REPORTED DATE OF THE INCIDENT AND IMPLANTATION WAS (B)(6) 2026. ADDITIONAL DETAILS REGARDING THE CLINICAL CIRCUMSTANCES, REASON FOR EXPLANT, AND PATIENT OUTCOME WERE NOT PROVIDED AT THE TIME OF REPORTING, AND FURTHER INFORMATION WILL BE REQUESTED TO SUPPORT THE INVESTIGATION. DEVICE PROBLEM SUMMARY: THE REPORTED DEVICE ISSUE INVOLVES THE EXPLANTATION OF THE ON-X AORTIC VALVE (ONXACE-21) SHORTLY AFTER IMPLANTATION, AS INDICATED BY THE IRC NOTATION. NO SPECIFIC ALLEGATION OF DEVICE MALFUNCTION, FAILURE MODE, OR PERFORMANCE DEFICIENCY WAS DOCUMENTED IN THE INITIAL REPORT. AT THIS TIME, IT REMAINS UNCLEAR WHETHER THE EXPLANT WAS DUE TO DEVICE-RELATED FACTORS, PROCEDURAL CONSIDERATIONS, OR PATIENT-SPECIFIC ANATOMY. ADDITIONAL FOLLOW-UP IS REQUIRED TO DETERMINE IF A DEVICE PROBLEM CONTRIBUTED TO THE EVENT. PATIENT IMPACT SUMMARY: PATIENT IMPACT IS CURRENTLY UNKNOWN BASED ON THE AVAILABLE INFORMATION. WHILE THE DEVICE WAS REPORTEDLY IMPLANTED AND SUBSEQUENTLY EXPLANTED, NO DETAILS WERE PROVIDED REGARDING COMPLICATIONS, ADVERSE CLINICAL OUTCOMES, OR THE PATIENT¿S CONDITION FOLLOWING THE PROCEDURE. FURTHER CLINICAL INFORMATION IS NEEDED TO ASSESS WHETHER THE PATIENT EXPERIENCED ANY HARM, REQUIRED ADDITIONAL INTERVENTION, OR HAD ANY LASTING EFFECTS ASSOCIATED WITH THE EVENT. THIS INVESTIGATION IS RELEGATED TO ONXACE-21 SERIAL NUMBER (B)(6) (2026), WITH AN ALLEGATION OF THE DEVICE BEING IMPLANTED AND SUBSEQUENTLY EXPLANTED, AS INDICATED BY THE IMPLANT REGISTRATION CARD NOTING ¿NOT KEPT IMPLANTED THEN EXPLANTED.¿