BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM - UNKNOWN CONFIGURATION

    MDR report key: 20723617 · Received November 19, 2024

    Report

    Report Number
    1063481-2024-00027
    Event Type
    Injury
    Date Received
    November 19, 2024
    Report Date
    December 19, 2024
    Manufacturer
    ARTIVION, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K172085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE ABSTRACT ¿A CASE OF IMMUNE MEDIATED ENDOCARDITIS¿ BY G. ROBERTSON, ET AL., WAS RECENTLY PUBLISHED IN ANN ALLERGY ASTHMA IMMUNOL 133(2024) S101-S210 REPORTS THE USED O PHOTOFIX USED DURING AN AV CANAL REPAIR. AN ECHOCARDIOGRAM PERFORMED 3.5 MONTHS POST-OP REPORTED AN IRREGULARLY-SHAPED MASS ABOVE THE RIGHT-SIDED AV VALVE. THE MASS WAS EXCISED AND THE PATIENT UNDERWENT SUCCESSFUL TREATMENT WITH ANAKINRA, AND IL-1 INHIBITOR. IT IS UNCLEAR IF THIS EVENT IS RELATED TO THE PHOTOFIX, OR OTHER DEVICES USED DURING THE REPAIR. THIS INVESTIGATION IS RELEGATED TO PHOTOFIX OF UNKNOWN CONFIGURATION FOR PHARMACEUTICAL AND SURGICAL INTERVENTION. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. NO ADDITIONAL INFORMATION FORTHCOMING. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A DEFINITIVE LOT/SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. ACCORDING TO THE ABSTRACT ¿A CASE OF IMMUNE MEDIATED ENDOCARDITIS¿ BY G. ROBERTSON, ET AL., WAS RECENTLY PUBLISHED IN ANN ALLERGY ASTHMA IMMUNOL 133(2024) S101-S210 REPORTS THE USED PHOTOFIX USED DURING AN AV CANAL REPAIR. AN ECHOCARDIOGRAM PERFORMED 3.5 MONTHS POST-OP REPORTED AN IRREGULARLY-SHAPED MASS ABOVE THE RIGHT-SIDED AV VALVE. THE MASS WAS EXCISED AND THE PATIENT UNDERWENT SUCCESSFUL TREATMENT WITH ANAKINRA, AND IL-1 INHIBITOR. NO ADDITIONAL INFORMATION WAS PROVIDED RELATED TO THE COMPOSITION OF THE EXCISED MASS. IT IS UNCLEAR IF THIS EVENT IS RELATED TO THE PHOTOFIX, OR OTHER DEVICES USED DURING THE REPAIR. THIS INVESTIGATION IS RELEGATED TO PHOTOFIX OF UNKNOWN CONFIGURATION FOR SURGICAL INTERVENTION AND SUBSEQUENT PHARMACEUTICAL TREATMENT. NO ADDITIONAL INFORMATION RELATED TO THE EVENT REPORTED. THE PATIENT UNDERWENT ANOTHER 3 SURGICAL PROCEDURES TO REMOVE THE RECURRENT MASSES THAT WERE NOTED ON THE ECHOCARDIOGRAM. PER THE INFORMATION IN THE ABSTRACT, IT APPEARS THE PHOTOFIX PATCH REMAINS IMPLANTED. ADDITIONALLY, THE PATIENT WAS STARTED ON A PHARMACEUTICAL TREATMENT USING ANAKINRA, AN IMMUNOSUPPRESSANT. THE AUTHORS ¿SUSPECT THAT THE INITIAL CARDIAC SURGICAL REPAIR TRIGGERED AND INFLAMMATORY PROCESS LEADING TO THE MASS FORMATION IN THE PATIENT.¿ THE PATIENT¿S IMPROVEMENT ON ANAKINRA MAY BE ATTRIBUTABLE TO DOWNREGULATION OF THE IMMUNE RESPONSE. THE INSTRUCTIONS FOR USE (IFU) LIST (EPICARDIAL) INFLAMMATORY REACTIONS AND REJECTION AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF PHOTOFIX. NO PATHOLOGY REPORTS OF THE EXPLANTED TISSUE SAMPLES WERE PROVIDED, AND NO SAMPLES WERE RETURNED FOR EVALUATION. ADDITIONALLY, AS NOTED BY THE AUTHORS, A SIMILAR CLINICAL SEQUELA HAS BEEN PREVIOUSLY REPORTED IN A CASE REPORT BY MULLER ET AL, WITH SUCCESSFUL TREATMENT WITH ANAKINRA. GIVEN THE SUCCESSFUL OUTCOME WITH THE USE OF ANAKINRA, AN IMMUNOSUPPRESSANT, THE PATIENT EXPERIENCED AN INFLAMMATORY/IMMUNE RESPONSE TO THE INITIAL SURGICAL REPAIR, WHEREIN PHOTOFIX WAS USED. INFLAMMATORY/IMMUNE RESPONSE ARE NOT UNEXPECTED OUTCOME WITH THE USE OF PHOTOFIX. ADEQUATE PRECAUTIONS ARE NOTED IN THE IFU. NO ACTIONS ARE REQUIRED AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. 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 ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.

    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 ¿ FORMERLY CRYOLIFE/JOTEC.

    Description of Event or Problem · 0

    ACCORDING TO THE ABSTRACT ¿A CASE OF IMMUNE MEDIATED ENDOCARDITIS¿ BY G. ROBERTSON, ET AL., WAS RECENTLY PUBLISHED IN ANN ALLERGY ASTHMA IMMUNOL 133(2024)S101-S210 REPORTS THE USE OF PHOTOFIX DURING AN AV CANAL REPAIR. AN ECHOCARDIOGRAM PERFORMED 3.5 MONTHS POST-OP REPORTED AN IRREGULARLY-SHAPED MASS ABOVE THE RIGHT-SIDED AV VALVE. THE MASS WAS EXCISED AND THE PATIENT UNDERWENT SUCCESSFUL TREATMENT WITH ANAKINRA, AND IL-1 INHIBITOR. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. IT IS UNCLEAR IF THIS EVENT IS RELATED TO THE PHOTOFIX OR OTHER DEVICES USED DURING THE REPAIR. THIS INVESTIGATION IS RELEGATED TO PHOTOFIX OF UNKNOWN CONFIGURATION FOR CHEMICAL AND SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307547 PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM - UNKNOWN CONFIGURATION PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ ARTIVION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Male Other| R