BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT (ONXA

    MDR report key: 21593943 · Received March 13, 2025

    Report

    Report Number
    1649833-2025-00006
    Event Type
    Death
    Date Received
    March 13, 2025
    Date of Event
    August 21, 2024
    Report Date
    May 2, 2025
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INITIAL NOTIFICATION ON 02/28/2025, " THIS PUBLICATION ¿DECELLULARIZED AORTIC HOMOGRAFT¿S VERSUS MECHANICAL COMPOSITE GRAFTS FOR AORTIC ROOT REPLACEMENT¿ BY ANDREEVA, ET ALL PUBLISHED ON 21AUG 2024 IN THE EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY WAS DISCOVERED DURING THE MOST RECENT ON-X AAP EU MDR CYCLE. THIS STUDY INCLUDED 289 PATIENTS UNDERGOING AAR (AORTIC ROOT REPLACEMENT) IN AN ELECTIVE SETTING WITH DAH (DECELLULARIZED AORTIC HOMOGRAFT) OR MCVG (MECHANICAL COMPOSITE VALVE GRAFT) BETWEEN 2000 AND 2022. DATA WAS COLLECTED RETROSPECTIVELY FROM THE INSTITUTIONAL HOSPITAL DATABASE AND PROSPECTIVELY THROUGH OUTPATIENT VISITS AND PHONE CALLS. ALL-CAUSE MORTALITY WAS THE PRIMARY ENDPOINT AND A COMPOSITE END POINT OF SVD, NSVD (NON- STRUCTURAL VALVE DETERIORATION), BLEEDING, THROMBOTIC AND EMBOLIC EVENTS WAS CREATED FOR ASSESSMENT OF EVENT-FREE SURVIVAL. THE FOLLOWING CONDUITS WERE USED AS MCVG: SJM REGENT (ABBOTT, ABBOTT PARK, IL, USA) N = 107, 49.5%, CARBOMEDICS CARBOSEAL (LIVANOVA, SALUGGIA, ITALY) N = 83, 38.4%, ON-X (ARTIVION, KENNESAW, GA, USA) N =24, 11.1%, MEDTRONIC OPEN PIVOT (MEDTRONIC, MINNEAPOLIS, MN, USA) N = 2, 0.9%. FOUR DEATHS WERE REPORTED FOR 30-DAY MORTALITY THEY WERE FULMINANT SEPSIS, MASSIVE INTRACRANIAL HEMORRHAGE, MASSIVE PERICARDIAL EFFUSION AND MULTIORGAN FAILURE WITH MYOCARDIAL INFARCTION. OTHER EVENTS REPORTED WERE BLEEDING, THROMBOSIS, EMBOLIZATION, ENDOCARDITIS, STRUCTURAL VALVE DETERIORATION, PERMANENT PACEMAKER IMPLANTATION AND RE-INTERVENTION. THE CONCLUSION PRESENTED WAS ¿AORTIC ROOT REPLACEMENT WITH EITHER A MCVG OR A DECELLULARIZED AORTIC HOMOGRAFTS SHOWED VERY LOW MORTALITY IN AN ELECTIVE SETTING. PATIENTS AFTER DAH IMPLANTATION DEMONSTRATED SIGNIFICANTLY HIGHER FREEDOM FROM VALVE-RELATED ADVERSE EVENTS DURING MID- TERM FOLLOW-UP. DAH PRESENT A PROMISING TREATMENT OPTION FOR YOUNG PATIENTS REQUIRING ARR; HOWEVER, FURTHER DATA ON LONG- TERM DURABILITY ARE NEEDED¿." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. NO ADDITIONAL INFORMATION FORTHCOMING. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS PATIENT INFORMATION, SERIAL NUMBERS, NOR DATES OF IMPLANT WERE PROVIDED. THE INFORMATION WAS REVIEWED. THIS INVESTIGATION REVIEWS THE CLINICAL OUTCOMES PRESENTED IN THE 2024 PUBLICATION ¿DECELLULARIZED AORTIC HOMOGRAFTS VERSUS MECHANICAL COMPOSITE GRAFTS FOR AORTIC ROOT REPLACEMENT¿ BY ANDREEVA ET AL. THE STUDY IS A SINGLE-CENTER RETROSPECTIVE COHORT ANALYSIS CONDUCTED AT THE MEDICAL UNIVERSITY OF VIENNA, ENCOMPASSING 289 ADULT PATIENTS WHO UNDERWENT ELECTIVE AORTIC ROOT REPLACEMENT (ARR) BETWEEN 2000 AND 2022. PATIENTS INCLUDED IN THE STUDY RECEIVED EITHER A MECHANICAL COMPOSITE VALVE GRAFT (MCVG) OR A DECELLULARIZED AORTIC HOMOGRAFT (DAH), WHILE THOSE UNDERGOING URGENT OR EMERGENT PROCEDURES WERE EXCLUDED. OF THE 289 PATIENTS, 216 RECEIVED AN MCVG AND 73 RECEIVED A DAH. THE MEAN AGE WAS 48.5 ± 11.5 YEARS, WITH MCVG PATIENTS AVERAGING 49 YEARS AND DAH PATIENTS 47 YEARS. THE MAJORITY OF PATIENTS WERE MALE (79.6%), WITH 83.3% IN THE MCVG GROUP AND 68.4% IN THE DAH GROUP. AMONG THOSE TREATED WITH MCVG, THE FOLLOWING CONDUITS WERE USED: SJM REGENT (49.5%, N=107), CARBOMEDICS CARBOSEAL (38.4%, N=83), ON-X (11.1%, N=24), AND MEDTRONIC OPEN PIVOT (0.9%, N=2). THE STUDY REPORTED A 30-DAY MORTALITY RATE OF 1% (N=3), ALL OCCURRING IN THE MCVG GROUP. OPERATIVE MORTALITY WAS 1.4% (N=4), ALSO CONFINED TO THE MCVG GROUP. ONE-YEAR SURVIVAL WAS 100% IN THE DAH GROUP AND 95.8% IN THE MCVG GROUP, WHILE THREE-YEAR SURVIVAL RATES WERE 98.6% AND 94.4%, RESPECTIVELY. IN TERMS OF VALVE-RELATED COMPLICATIONS IN THE MCVG COHORT, BLEEDING EVENTS WERE OBSERVED IN 14 PATIENTS (6.5%) AT 1 YEAR AND 2.6% AT 3 YEARS. THESE INCLUDED THREE CASES OF CEREBRAL BLEEDING (1.4%) AND 11 PERIPHERAL (5.1%). VALVE THROMBOSIS OCCURRED IN TWO PATIENTS (0.9%) AT BOTH 1 AND 3 YEARS. EMBOLIZATION EVENTS WERE REPORTED IN 14 PATIENTS (6.5%) AT 1 YEAR AND 4.4% AT 3 YEARS, OF WHICH 12 (5.6%) WERE CEREBRAL EMBOLISMS. THESE LED TO STROKE IN 10 CASES (4.6%) AND TRANSIENT ISCHEMIC ATTACK IN TWO CASES (0.9%). PERMANENT PACEMAKER IMPLANTATION WAS REQUIRED IN 15 PATIENTS (6.9%) AT 1 YEAR AND 4.7% AT 3 YEARS. AORTIC VALVE ENDOCARDITIS WAS OBSERVED IN 10 PATIENTS (4.6%), WITH AN INCIDENCE OF 1.2% AT 1 YEAR AND 1.9% AT 3 YEARS; SIX PATIENTS (2.8%) REQUIRED REOPERATION. NOTABLY, NO CASES OF STRUCTURAL VALVE DETERIORATION (SVD) WERE REPORTED IN THE MCVG GROUP. REINTERVENTION WAS NECESSARY IN 12 MCVG PATIENTS (5.6%) AT 1 YEAR AND 3.1% AT 3 YEARS, WITH NO REINTERVENTIONS REPORTED IN THE DAH GROUP. SEVEN OF THESE REINTERVENTIONS (3.2%) WERE VALVE-RELATED, INCLUDING SIX CASES OF ENDOCARDITIS AND ONE DUE TO VALVE THROMBOSIS. FOUR REINTERVENTIONS (1.9%) WERE RELATED TO THE AORTA AND INCLUDED PROCEDURES SUCH AS AORTIC ARCH REPLACEMENT, THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR TYPE B DISSECTIONS, AND RE-ARR FOR PSEUDOANEURYSM. ONE REINTERVENTION (0.4%) WAS PERFORMED FOR POSTOPERATIVE LEFT MAIN DISSECTION, WHICH REQUIRED CORONARY ARTERY BYPASS GRAFTING. ACCORDING TO THE STUDY AUTHORS, ELECTIVE ARR USING EITHER MCVG OR DAH WAS ASSOCIATED WITH LOW EARLY MORTALITY. HOWEVER, PATIENTS IN THE DAH GROUP DEMONSTRATED SIGNIFICANTLY GREATER FREEDOM FROM VALVE RELATED ADVERSE EVENTS DURING MID-TERM FOLLOW-UP. THE AUTHORS SUGGEST THAT DAH REPRESENTS A PROMISING TREATMENT OPTION FOR YOUNG PATIENTS REQUIRING ARR, THOUGH FURTHER DATA ARE NEEDED TO ASSESS LONG-TERM DURABILITY. ALL REPORTED COMPLICATIONS AND MORTALITY EVENTS ARE CONSISTENT WITH THE KNOWN RISKS OUTLINED IN THE ON-X® VALVE¿S INSTRUCTIONS FOR USE (IFU). THIS CLINICAL OUTCOME ANALYSIS IS BASED ON A SINGLE-CENTER EXPERIENCE INVOLVING 289 PATIENTS WHO UNDERWENT ELECTIVE AORTIC ROOT REPLACEMENT (ARR) USING EITHER A MECHANICAL COMPOSITE VALVE GRAFT (MCVG) OR A DECELLULARIZED AORTIC HOMOGRAFT (DAF). HOWEVER, BASED ON THE INFORMATION PROVIDED IN THE PUBLICATION, IT IS NOT POSSIBLE TO IDENTIFY WHICH PATIENTS RECEIVED THE ON-X AORTIC AAP IMPLANT VERSUS A MCVG FROM ANOTHER MANUFACTURER. CONSEQUENTLY, IT IS NOT FEASIBLE TO ATTRIBUTE SPECIFIC ADVERSE EVENTS OR MORTALITY OUTCOMES TO THE AAP DEVICE. THEREFORE, WE CANNOT ASSESS THE AAP DEVICE¿S CONTRIBUTION, IF ANY, TO THE REPORTED EVENTS. IT IS IMPORTANT TO NOTE THAT ALL REPORTED COMPLICATIONS AND MORTALITY OUTCOMES ARE IDENTIFIED IN THE ON-X AAP INSTRUCTIONS FOR USE (IFU) AS KNOWN RISKS. NO FURTHER ACTION IS REQUIRED WITHOUT FURTHER INFORMATION. BASED ON THE INFORMATION PROVIDED IN THE PUBLICATION, IT IS NOT POSSIBLE TO IDENTIFY WHICH PATIENTS RECEIVED THE ON-X AORTIC AAP IMPLANT VERSUS A MCVG FROM ANOTHER MANUFACTURER. CONSEQUENTLY, IT IS NOT FEASIBLE TO ATTRIBUTE SPECIFIC ADVERSE EVENTS OR MORTALITY OUTCOMES TO THE AAP DEVICE. THEREFORE, WE CANNOT ASSESS THE AAP DEVICE¿S CONTRIBUTION, IF ANY, TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION AND THE IFU ADEQUATELY COMMUNICATES RISK. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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 · 0

    ACCORDING TO THE INITIAL NOTIFICATION ON 02/28/2025, " THIS PUBLICATION ¿DECELLULARIZED AORTIC HOMOGRAFT¿S VERSUS MECHANICAL COMPOSITE GRAFTS FOR AORTIC ROOT REPLACEMENT¿ BY ANDREEVA, ET ALL PUBLISHED ON 21AUG 2024 IN THE EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY WAS DISCOVERED DURING THE MOST RECENT ON-X AAP EU MDR CYCLE. THIS STUDY INCLUDED 289 PATIENTS UNDERGOING AAR (AORTIC ROOT REPLACEMENT) IN AN ELECTIVE SETTING WITH DAH (DECELLULARIZED AORTIC HOMOGRAFT) OR MCVG (MECHANICAL COMPOSITE VALVE GRAFT) BETWEEN 2000 AND 2022. DATA WAS COLLECTED RETROSPECTIVELY FROM THE INSTITUTIONAL HOSPITAL DATABASE AND PROSPECTIVELY THROUGH OUTPATIENT VISITS AND PHONE CALLS. ALL-CAUSE MORTALITY WAS THE PRIMARY ENDPOINT AND A COMPOSITE END POINT OF SVD, NSVD (NON- STRUCTURAL VALVE DETERIORATION), BLEEDING, THROMBOTIC AND EMBOLIC EVENTS WAS CREATED FOR ASSESSMENT OF EVENT-FREE SURVIVAL. THE FOLLOWING CONDUITS WERE USED AS MCVG: SJM REGENT (ABBOTT, ABBOTT PARK, IL, USA) N = 107, 49.5%, CARBOMEDICS CARBOSEAL (LIVANOVA, SALUGGIA, ITALY) N = 83, 38.4%, ON-X (ARTIVION, KENNESAW, GA, USA) N =24, 11.1%, MEDTRONIC OPEN PIVOT (MEDTRONIC, MINNEAPOLIS, MN, USA) N = 2, 0.9%. FOUR DEATHS WERE REPORTED FOR 30-DAY MORTALITY THEY WERE FULMINANT SEPSIS, MASSIVE INTRACRANIAL HEMORRHAGE, MASSIVE PERICARDIAL EFFUSION AND MULTIORGAN FAILURE WITH MYOCARDIAL INFARCTION. OTHER EVENTS REPORTED WERE BLEEDING, THROMBOSIS, EMBOLIZATION, ENDOCARDITIS, STRUCTURAL VALVE DETERIORATION, PERMANENT PACEMAKER IMPLANTATION AND RE-INTERVENTION. THE CONCLUSION PRESENTED WAS ¿AORTIC ROOT REPLACEMENT WITH EITHER A MCVG OR A DECELLULARIZED AORTIC HOMOGRAFTS SHOWED VERY LOW MORTALITY IN AN ELECTIVE SETTING. PATIENTS AFTER DAH IMPLANTATION DEMONSTRATED SIGNIFICANTLY HIGHER FREEDOM FROM VALVE-RELATED ADVERSE EVENTS DURING MID- TERM FOLLOW-UP. DAH PRESENT A PROMISING TREATMENT OPTION FOR YOUNG PATIENTS REQUIRING ARR; HOWEVER, FURTHER DATA ON LONG- TERM DURABILITY ARE NEEDED¿."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804214 ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT (ONXA HEART VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| O| D