ON-X VALVE UNKNOWN CONFIGURATION

Description of Event or Problem

DESCRIPTION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2026 FROM ARTIVION REPRESENTATIVE (B)(6), A TRAVELING NURSE REPORTED OBSERVING AN ISSUE INVOLVING AN ON-X MECHANICAL VALVE DURING A PROCEDURE AT A FACILITY IN (B)(6) (UNIVERSITY OF (B)(6) MEDICAL CENTER). THE EVENT WAS DESCRIBED BY THE REPORTER AS A VALVE LEAFLET HAVING ¿EXPLODED,¿ WHICH WERE THE REPORTER¿S EXACT WORDS. THE EVENT WAS STATED TO HAVE OCCURRED IN (B)(6) 2025. NO ADDITIONAL PROCEDURAL, PATIENT, OR DEVICE-SPECIFIC DETAILS (E.G., MODEL, SIZE, OR SERIAL NUMBER) WERE PROVIDED. AN IMAGE WAS REFERENCED AND ATTACHED FOR REVIEW. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FURTHER ASSESS THE REPORTED EVENT. DEVICE PROBLEM SUMMARY: THE REPORTED ISSUE INVOLVES AN ALLEGED STRUCTURAL FAILURE OF AN ON-X MECHANICAL VALVE LEAFLET, DESCRIBED AS HAVING ¿EXPLODED¿ DURING USE. BASED ON THE LIMITED INFORMATION AVAILABLE, THIS SUGGESTS A POTENTIAL FRACTURE OR BREAKAGE OF THE LEAFLET COMPONENT. HOWEVER, NO DEVICE IDENTIFIERS, RETURN PRODUCT, OR FORMAL EVALUATION RESULTS ARE AVAILABLE AT THIS TIME TO CONFIRM THE NATURE, CAUSE, OR EXTENT OF THE REPORTED FAILURE. FOLLOW-UP HAS BEEN INITIATED TO OBTAIN ADDITIONAL DETAILS AND CLARIFY THE REPORTED ISSUE. PATIENT IMPACT SUMMARY: AT THE TIME OF REPORTING, NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME OR CLINICAL IMPACT ASSOCIATED WITH THE REPORTED EVENT. THEREFORE, THE EFFECT ON THE PATIENT¿S CONDITION OR ANY RESULTING COMPLICATIONS CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO ASSESS POTENTIAL PATIENT IMPACT. INVESTIGATION STATEMENT: THIS INVESTIGATION IS RELEGATED TO AN UNKNOWN ON-X MECHANICAL VALVE (2026), WITH AN ALLEGATION OF LEAFLET STRUCTURAL FAILURE DESCRIBED AS ¿EXPLOSION.¿ AT THE TIME OF REPORTING, THE DEVICE PRODUCT CODE AND SERIAL NUMBER ARE UNKNOWN.

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 ¿ FORMERLY CRYOLIFE/JOTEC.