BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONARY VALVE & CONDUIT SG

    MDR report key: 20622471 · Received November 6, 2024

    Report

    Report Number
    1063481-2024-00026
    Event Type
    Injury
    Date Received
    November 6, 2024
    Report Date
    January 7, 2025
    Manufacturer
    ARTIVION, INC.
    Product Code
    OHA
    PMA / PMN Number
    K092021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    THE MANUSCRIPTS LISTED ABOVE COVER A COMPREHENSIVE DATA COLLECTION PERIOD SPANNING 2000 THROUGH 2010 AS RETROSPECTIVE REVIEWS REPORTING ON THE OUTCOMES OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) USED DURING RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION. ECHOCARDIOGRAPHIC DATA WERE REVIEWED TO EVALUATE VALVE PERFORMANCE. THE CLINICAL OUTCOMES INCLUDE EVENTS OF VALVULAR INSUFFICIENCY/REGURGITATION AND/OR STENOSIS AND SUBSEQUENT REOPERATIONS AS DEEMED APPROPRIATE. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE SPECIFIC TIME TO OCCURRENCE OF THESE EVENTS FOR EACH PATIENT OR DIRECT CORRELATION TO THE USE OF THE ALLOGRAFTS OR IF THE EVENTS ARE MUTUALLY EXCLUSIVE. THE CARDIAC ALLOGRAFTS UNDERGO INSPECTION BY THE DISSECTOR AS WELL AS BY THE INSPECTOR PRIOR TO FINAL PACKAGING. THE INSTRUCTIONS FOR USE (IFU) LISTS VALVULAR AND PERIVALVULAR INSUFFICIENCY (REGURGITATION) AND VALVULAR AND CONDUIT STENOSIS AS KNOWN ADVERSE EVENTS WITH THE USE OF CARDIAC ALLOGRAFTS AND HAVE BEEN REPORTED WITH OTHER HEART VALVE PROSTHESES AND SHOULD BE CONSIDERED IN THE DECISION OF GRAFT SELECTION. REOPERATION IS A WELL-ESTABLISHED TREATMENT PARADIGM FOR PATIENTS PRESENTING WITH COMPLEX CARDIAC HISTORY WITH THESE CLINICAL DIAGNOSES. THE SG CRYOPRESERVED HUMAN TISSUE A/DFMEA AND PFMEA WERE REVIEWED, AND THE REPORTED EVENTS ARE 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 2000-2010. 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. DUE TO THE LIMITED INFORMATION, IT CANNOT BE DETERMINED IF THE REPORTED EVENTS ARE DIRECTLY RELATED TO THE ALLOGRAFTS. THE ADVERSE EVENTS REPORTED IN THE PUBLICATIONS ARE NOT UNEXPECTED CLINICAL OUTCOMES OF THE ALLOGRAFTS IN THIS PATIENT POPULATION. ADEQUATE PRECAUTIONS ARE LISTED IN THE IFU. 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

    THE DIVISIONS OF PEDIATRIC CARDIOVASCULAR SURGERY AND PEDIATRIC CARDIOLOGY, UNIVERSITY OF MICHIGAN MEDICAL SCHOOL, ANN ARBOR, MICHIGAN, HAVE PUBLISHED ON THEIR EXPERIENCE WITH SYNERGRAFT-PROCESSED ALLOGRAFTS. THE PUBLICATIONS ARE AS FOLLOWS: ¿SUPERIOR DURABILITY OF SYNERGRAFT PULMONARY ALLOGRAFTS COMPARED WITH STANDARD CRYOPRESERVED ALLOGRAFTS¿. ANN THORAC SURG 2005;80:1610¿4. ¿PERFORMANCE OF CRYOVALVE SG DECELLULARIZED PULMONARY ALLOGRAFTS COMPARED WITH STANDARD CRYOPRESERVED ALLOGRAFTS¿. ANN THORAC SURG 2009;88:849 ¿55. ¿DECELLULARIZED VERSUS STANDARD CRYOPRESERVED VALVE ALLOGRAFTS FOR RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION: A SINGLE-INSTITUTION COMPARISON¿. J THORAC CARDIOVASC SURG 2012;143:543-9). ¿PERFORMANCE OF SYNERGRAFT DECELLULARIZED PULMONARY ALLOGRAFTS COMPARED WITH STANDARD CRYOPRESERVED ALLOGRAFTS: RESULTS FROM MULTIINSTITUTIONAL DATA¿. THE FULL MANUSCRIPT WAS LATER PUBLISHED IN 2017: ANN THORAC SURG 2017;103:869¿7. MANUSCRIPTS ARE RETROSPECTIVE REVIEWS REPORTING ON THE OUTCOMES OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) COMPARED TO THOSE OF STANDARD PROCESSED CRYOPRESERVED PULMONARY VALVES (CRYOLIFE, PV00) USED FOR PULMONARY VALVE REPLACEMENTS. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 2000 ¿ 2010, WITH THE OVERALL USE OF 163 SGPV AND 124 PV00. AS NOTED ABOVE, THE SINGLE CENTER DATASET IS A SUBSET OF THIS LARGER SERIES. THE AUTHORS CONCLUDE ¿WHEN COMPARED WITH STANDARD ALLOGRAFTS, CRYOVALVE SGS DEMONSTRATE SUPERIOR FREEDOM FROM SIGNIFICANT INSUFFICIENCY AT INTERMEDIATE FOLLOW-UP. THIS EVENT IS ASSOCIATED WITH SGPV00, UNKNOWN SIDS FROM UNKNOWN DONORS WITH AN ALLEGATION OF VALVULAR INSUFFICIENCY/REGURGITATION, STENOSIS AND REOPERATION.

    Description of Event or Problem · 0

    THE DIVISIONS OF PEDIATRIC CARDIOVASCULAR SURGERY AND PEDIATRIC CARDIOLOGY, UNIVERSITY OF MICHIGAN MEDICAL SCHOOL, ANN ARBOR, MICHIGAN, HAVE PUBLISHED ON THEIR EXPERIENCE WITH SYNERGRAFT-PROCESSED ALLOGRAFTS. THE PUBLICATIONS ARE AS FOLLOWS: ¿SUPERIOR DURABILITY OF SYNERGRAFT PULMONARY ALLOGRAFTS COMPARED WITH STANDARD CRYOPRESERVED ALLOGRAFTS¿. ANN THORAC SURG 2005; 80:1610¿4. ¿PERFORMANCE OF CRYOVALVE SG DECELLULARIZED PULMONARY ALLOGRAFTS COMPARED WITH STANDARD CRYOPRESERVED ALLOGRAFTS¿. ANN THORAC SURG 2009; 88:849 ¿55. ¿DECELLULARIZED VERSUS STANDARD CRYOPRESERVED VALVE ALLOGRAFTS FOR RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION: A SINGLE-INSTITUTION COMPARISON¿. J THORAC CARDIOVASC SURG 2012; 143:543-9). ¿PERFORMANCE OF SYNERGRAFT DECELLULARIZED PULMONARY ALLOGRAFTS COMPARED WITH STANDARD CRYOPRESERVED ALLOGRAFTS: RESULTS FROM MULTIINSTITUTIONAL DATA¿. THE FULL MANUSCRIPT WAS LATER PUBLISHED IN 2017: ANN THORAC SURG 2017; 103:869¿7. MANUSCRIPTS ARE RETROSPECTIVE REVIEWS REPORTING ON THE OUTCOMES OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) COMPARED TO THOSE OF STANDARD PROCESSED CRYOPRESERVED PULMONARY VALVES (CRYOLIFE, PV00) USED FOR PULMONARY VALVE REPLACEMENTS. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 2000 ¿ 2010, WITH THE OVERALL USE OF 163 SGPV AND 124 PV00. AS NOTED, ABOVE, THE SINGLE CENTER DATASET IS A SUBSET OF THIS LARGER SERIES. THE AUTHORS CONCLUDE ¿WHEN COMPARED WITH STANDARD ALLOGRAFTS, CRYOVALVE SGS DEMONSTRATE SUPERIOR FREEDOM FROM SIGNIFICANT INSUFFICIENCY AT INTERMEDIATE FOLLOW-UP. THIS EVENT IS ASSOCIATED WITH SGPV00, UNKNOWN SIDS FROM UNKNOWN DONORS WITH AN ALLEGATION OF VALVULAR INSUFFICIENCY/REGURGITATION, STENOSIS AND REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997633 PULMONARY VALVE & CONDUIT SG HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT OHA ARTIVION, INC. SGPV00 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H