BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONARY VALVE & CONDUIT

    MDR report key: 20613744 · Received November 5, 2024

    Report

    Report Number
    1063481-2024-00025
    Event Type
    Injury
    Date Received
    November 5, 2024
    Report Date
    December 16, 2024
    Manufacturer
    ARTIVION, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    THE SECTION OF CARDIOTHORACIC SURGERY, INDIANA UNIVERSITY SCHOOL OF MEDICINE, INDIANAPOLIS, IN, HAVE PUBLISHED ON THEIR EXPERIENCES WITH CRYOLIFE PROCESSED HOMOGRAFTS INCLUDING BOTH SYNERGRAFT AS WELL AS STANDARD PROCESSED PULMONARY HOMOGRAFT. THE PUBLICATIONS ARE AS FOLLOWS: ¿FATE OF THE AUTOGRAFT AND HOMOGRAFT FOLLOWING ROSS AORTIC VALVE REPLACEMENT: REOPERATIVE FREQUENCY, OUTCOME, AND MANAGEMENT¿. THE JOURNAL OF HEART VALVE DISEASE 2006;15:253-260. ¿THE ROSS FULL ROOT REPLACEMENT IN ADULTS WITH BICUSPID AORTIC VALVE DISEASE¿. THE JOURNAL OF HEART VALVE DISEASE 2011;20:332-340. BOTH MANUSCRIPTS ARE RETROSPECTIVE REVIEWS REPORTING ON THE OUTCOMES OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) AND STANDARD PROCESSED CRYOPRESERVED PULMONARY VALVES (CRYOLIFE, PV00) USED FOR PULMONARY VALVE REPLACEMENTS; HOWEVER THE REPORTED OUTCOMES DO NOT DIFFERENTIATE RELATION TO PROCESSING METHOD. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 1993 ¿ 2009. GIVEN THE OVERLAP OF THE REPORTING PERIOD OF THE 2 PUBLICATIONS, IT IS UNCLEAR WHICH PATIENTS ARE MUTUALLY EXCLUSIVE TO EITHER PUBLICATION. HOWEVER, IT APPEARS THE 2011 PUBLICATION IS A SUBSET OF THE ORIGINAL SERIES OF 167 PATIENTS: 22 SGPV, 140 STANDARD PV AND 5 GLUT FIXED BOVINE JUGULAR VEIN. HOMOGRAFT DYSFUNCTION WITH OBSTRUCTION, STENOSIS, REGURGITATION/INSUFFICIENCY, AND REOPERATION WERE NOTED IN THE HOMOGRAFTS USED FOR RECONSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNMET. THIS INVESTIGATION IS RELEGATED TO THE REPORTED PV00S. 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 DIRECT CORRELATION 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) 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 OBSTRUCTION AND 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 OF THE HOMOGRAFTS IN THIS PATIENT POPULATION. ADEQUATE PRECAUTIONS ARE LISTED IN THE IFU. THE STANDARD CRYOPRESERVED HUMAN TISSUE A/DFMEA AND PFMEA WERE REVIEWED THE REPORTED EVENTS WERE ADDRESSED. THE REPORTED TISSUE WAS NOT RETURNED TO ARTIVION AND NO SERIAL NUMBER WAS PROVIDED FOR AN INVESTIGATION. THE REPORT ORIGINATED FROM A PUBLICATION WHICH SPANNED FROM 1993-2009. 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 EVENTS 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. 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

    PUBLICATIONS, ¿FATE OF THE AUTOGRAFT AND HOMOGRAFT FOLLOWING ROSS AORTIC VALVE REPLACEMENT: REOPERATIVE FREQUENCY, OUTCOME, AND MANAGEMENT¿. THE JOURNAL OF HEART VALVE DISEASE 2006; 15:253-260. AND ¿THE ROSS FULL ROOT REPLACEMENT IN ADULTS WITH BICUSPID AORTIC VALVE DISEASE¿. THE JOURNAL OF HEART VALVE DISEASE 2011; 20:332-340. ARE RETROSPECTIVE REVIEWS REPORTING ON THE OUTCOMES OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) AND STANDARD PROCESSED CRYOPRESERVED PULMONARY VALVES (CRYOLIFE, PV00) USED FOR PULMONARY VALVE REPLACEMENTS; HOWEVER, THE REPORTED OUTCOMES DO NOT DIFFERENTIATE RELATION TO PROCESSING METHOD. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 1993 ¿ 2009. GIVEN THE OVERLAP OF THE REPORTING PERIOD OF THE 2 PUBLICATIONS, IT IS UNCLEAR WHICH PATIENTS ARE MUTUALLY EXCLUSIVE TO EITHER PUBLICATION. HOWEVER, IT APPEARS THE 2011 PUBLICATION IS A SUBSET OF THE ORIGINAL SERIES OF 167 PATIENTS: 22 SGPV, 140 STANDARD PV AND 5 GLUT FIXED BOVINE JUGULAR VEIN. HOMOGRAFT DYSFUNCTION WITH OBSTRUCTION, STENOSIS, REGURGITATION/INSUFFICIENCY, AND REOPERATION WERE NOTED IN THE HOMOGRAFTS USED FOR RECONSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THIS REPORT IS RELEGATED TO THE PV00 PRODUCT REPORTED IN THE LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132710 PULMONARY VALVE & CONDUIT HEART-VALVE, ALLOGRAFT MIE ARTIVION, INC. PV00 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other