ONX ASCENDING AORTIC 27/29
Received Jun 5, 2026 · Event occurred May 6, 2026
Report 1649833-2026-00017 · MDR key 25410972
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Heart Problem
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
DESCRIPTION SUMMARY: ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 08MAY2026 FROM SENIOR FIELD ASSURANCE ASSOCIATE, S.P., AN IMPLANT REGISTRATION CARD (IRC) WAS RECEIVED FOR A PATIENT IMPLANTED WITH TWO ON-X ASCENDING AORTIC PROSTHESIS (AAP) DEVICES AT (B)(6) HOSPITAL, (B)(6). THE FIRST DEVICE, ONXAAP-27/29 (SERIAL NUMBER (B)(6), WAS REPORTEDLY IMPLANTED ON (B)(6) 2025. THE SECOND DEVICE, ONXAAP-27/29 (SERIAL NUMBER (B)(6), WAS REPORTEDLY IMPLANTED ON (B)(6) 2026. THE REPORTER STATED, ¿RECEIVED AN AAP IRC FOR PATIENT WITH EXISTING AAP.¿ ADDITIONAL INFORMATION REGARDING THE CLINICAL CIRCUMSTANCES, REASON FOR IMPLANTATION OF THE SECOND DEVICE, AND PATIENT OUTCOME WAS NOT PROVIDED AT THE TIME OF REPORTING, AND FURTHER INFORMATION WILL BE REQUESTED TO SUPPORT THE INVESTIGATION. DEVICE PROBLEM SUMMARY: THE REPORTED EVENT INVOLVED RECEIPT OF AN IMPLANT REGISTRATION CARD INDICATING IMPLANTATION OF AN ADDITIONAL ONXAAP-27/29 DEVICE IN A PATIENT WITH AN EXISTING AAP IMPLANT. NO SPECIFIC ALLEGATION OF DEVICE MALFUNCTION, FAILURE, OR DEFICIENCY WAS PROVIDED WITHIN THE INITIAL REPORT. FURTHER INFORMATION WILL BE REQUESTED TO BETTER UNDERSTAND THE CIRCUMSTANCES ASSOCIATED WITH THE REPORTED EVENT. PATIENT IMPACT SUMMARY: AT THE TIME OF REPORTING, NO PATIENT INJURY, ADVERSE EVENT, OR CLINICAL COMPLICATION WAS ALLEGED OR REPORTED. PATIENT IMPACT REMAINS UNKNOWN PENDING RECEIPT OF ADDITIONAL INFORMATION. INVESTIGATION SUMMARY STATEMENT: THIS INVESTIGATION IS RELEGATED TO ONXAAP-27/29, SERIAL NUMBER (B)(6) (2026), WITH AN ALLEGATION INVOLVING RECEIPT OF AN IMPLANT REGISTRATION CARD FOR A PATIENT WITH AN EXISTING AAP IMPLANT.