BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 20600408 · Received November 4, 2024

    Report

    Report Number
    1063481-2024-00023
    Event Type
    Death
    Date Received
    November 4, 2024
    Report Date
    December 31, 2024
    Manufacturer
    ARTIVION, INC. ¿ KENNESAW
    Product Code
    OHA
    UDI-DI
    00877234000447
    PMA / PMN Number
    K092021
    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 NOTIFICATION "TWO PUBLICATIONS WERE REVIEWED RELATED TO THE CANADIAN ROSS REGISTRY DATABASE, THE PUBLICATIONS ARE AS FOLLOWS: ¿PULMONARY HOMOGRAFT DYSFUNCTION AFTER THE ROSS PROCEDURE USING DECELLULARIZED HOMOGRAFTS¿A MULTICENTER STUDY¿. J THORAC CARDIOVASCSURG 2022;163:1296-305. ¿THE ROSS PROCEDURE IS A SAFE AND DURABLE OPTION IN ADULTS WITH INFECTIVE ENDOCARDITIS: A MULTICENTRE STUDY¿. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 58 (2020) 537¿543. BOTH MANUSCRIPTS ARE MULTICENTER RETROSPECTIVE REVIEWS OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®/ARTIVION®, SGPV00) USED FOR THE ROSS PROCEDURE. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 2000 ¿ 2019, WITH THE OVERALL USE OF 466 SGPV VALVES. IT APPEARS THE 2020 PUBLICATION MAY BE A SUBSET OF THE LARGER 2022 DATASET. PULMONARY STENOSIS AND REOPERATION WERE NOTED IN THE SERIES AS WELL AS REINFECTION IN THE SUBGROUP OF PATIENTS PRESENTING WITH ENDOCARDITIS IN THE 2020 SERIES. AUTHORS CONCLUDE ¿THE USE OF DECELLULARIZED CRYOPRESERVED PULMONARY HOMOGRAFTS RESULTS IN A LOW INCIDENCE OF DYSFUNCTION AND REINTERVENTION AFTER THE ROSS PROCEDURE.¿ ¿IN SELECTED PATIENTS WITH IE, THE ROSS PROCEDURE IS A SAFE AND REASONABLE ALTERNATIVE WITH GOOD MID-TERM OUTCOMES. FREEDOM FROM RECURRENT INFECTION ON THE PULMONARY AUTOGRAFT IS EXCELLENT, LABELPORTING THE NOTION THAT A LIVING VALVE IN THE AORTIC POSITION PROVIDES GOOD RESISTANCE TO INFECTION.¿ MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE GONE UNMET. NO ADDITIONAL INFORMATION FORTHCOMING. THE AVAILABLE INFORMATION WAS REVIEWED. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE SPECIFIC TIME TO OCCURRENCE OF ANY OF THESE EVENTS OR IF THEY WERE MUTUALLY EXCLUSIVE EVENTS PER PATIENT OR THE RELATION TO THE USE OF THE HOMOGRAFTS. THE CARDIAC HOMOGRAFTS UNDERGO INSPECTION BY THE DISSECTOR AS WELL AS BY THE INSPECTOR PRIOR TO FINAL PACKAGING. THE INSTRUCTIONS FOR USE (IFU) LISTS VALVULAR AND CONDUIT STENOSIS, VALVULAR AND PERIVALVULAR INSUFFICIENCY (REGURGITATION), MICROBIAL INFECTION (ENDOCARDITIS) AND DEATH AS KNOWN ADVERSE EVENTS WITH THE USE OF CARDIAC HOMOGRAFTS AND HAVE BEEN REPORTED WITH OTHER HEART VALVE PROSTHESES AND SHOULD BE CONSIDERED IN THE DECISION OF GRAFT SELECTION. STENOSIS CAN CLINICALLY PRESENT AS HIGHER GRADIENTS ON DIAGNOSTIC EVALUATIONS. HEMORRHAGE MAY BE ATTRIBUTED TO DEGENERATION OR DEHISCENCE, BUT THE LOCATION OF THIS IS NOT CLEARLY DEFINED IN THE DETAILS OF THE MANUSCRIPT, SO IT REMAINS UNCLEAR OF THE RELATION TO THE HOMOGRAFT PLACEMENT. GIVEN THE COMPLICATED MEDICAL COMORBIDITIES OF THIS PATIENT POPULATION, IT IS PLAUSIBLE THAT THE REPORTED PULMONARY INFECTION, STROKE, AND PACEMAKER PLACEMENT(S) ARE NOT UNEXPECTED CLINICAL SEQUELAE. ESTABLISHED TREATMENT PARADIGMS FOR ANY OF THESE EVENTS MAY BE REOPERATION. DUE TO THE LIMITED INFORMATION, IT CANNOT BE DETERMINED IF THE REPORTED EVENTS ARE DIRECTLY RELATED TO THE HOMOGRAFTS. THE ADVERSE EVENTS REPORTED IN THE PUBLICATIONS ARE NOT UNEXPECTED CLINICAL OUTCOMES WITH THE USE OF HOMOGRAFTS IN THIS PATIENT POPULATION. ADEQUATE PRECAUTIONS ARE LISTED IN THE IFU. THE SG CRYOPRESERVED HUMAN TISSUE A/DFMEA AND PFMEA WERE REVIEWED AND THE REPORTED EVENTS ARE ADDRESSED. THIS COMPLAINT REPORTS ADVERSE EVENTS (AE) IDENTIFIED IN LITERATURE AND DOES NOT SPECIFY POTENTIAL CAUSES OF FAILURE. DUE TO THE LIMITED INFORMATION AND UNKNOWN TIME TO EVENTS, IT CANNOT BE DETERMINED IF THE REPORTED EVENTS ARE DIRECTLY RELATED TO THE ALLOGRAFTS. AS SUCH, NO RISK OCCURRENCE ANALYSIS WAS PERFORMED IN THIS REPORT. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION AND THE IFU ADEQUATELY COMMUNICATES RISK; THEREFORE A CAPA EVALUATION IS NOT WARRANTED AT THIS TIME. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. NO ACTIONS ARE REQUIRED AT THIS TIME. 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 NOTIFICATION FROM "TWO PUBLICATIONS WERE REVIEWED RELATED TO THE CANADIAN ROSS REGISTRY DATABASE, THE PUBLICATIONS ARE AS FOLLOWS: ¿PULMONARY HOMOGRAFT DYSFUNCTION AFTER THE ROSS PROCEDURE USING DECELLULARIZED HOMOGRAFTS¿A MULTICENTER STUDY¿. J THORAC CARDIOVASCSURG 2022;163:1296-305. ¿THE ROSS PROCEDURE IS A SAFE AND DURABLE OPTION IN ADULTS WITH INFECTIVE ENDOCARDITIS: A MULTICENTRE STUDY¿. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 58 (2020) 537¿543. BOTH MANUSCRIPTS ARE MULTICENTER RETROSPECTIVE REVIEWS OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®/ARTIVION®, SGPV00) USED FOR THE ROSS PROCEDURE. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 2000 ¿ 2019, WITH THE OVERALL USE OF 466 SGPV VALVES. IT APPEARS THE 2020 PUBLICATION MAY BE A SUBSET OF THE LARGER 2022 DATASET. PULMONARY STENOSIS AND REOPERATION WERE NOTED IN THE SERIES AS WELL AS REINFECTION IN THE SUBGROUP OF PATIENTS PRESENTING WITH ENDOCARDITIS IN THE 2020 SERIES. AUTHORS CONCLUDE ¿THE USE OF DECELLULARIZED CRYOPRESERVED PULMONARY HOMOGRAFTS RESULTS IN A LOW INCIDENCE OF DYSFUNCTION AND REINTERVENTION AFTER THE ROSS PROCEDURE.¿ ¿IN SELECTED PATIENTS WITH IE, THE ROSS PROCEDURE IS A SAFE AND REASONABLE ALTERNATIVE WITH GOOD MID-TERM OUTCOMES. FREEDOM FROM RECURRENT INFECTION ON THE PULMONARY AUTOGRAFT IS EXCELLENT, LABELPORTING THE NOTION THAT A LIVING VALVE IN THE AORTIC POSITION PROVIDES GOOD RESISTANCE TO INFECTION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175881 PULMONARY VALVE & CONDUIT SG HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT OHA ARTIVION, INC. ¿ KENNESAW SGPV00 00877234000447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O| H