BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXICOR FOR CARDIAC TISSUE REPAIR

    MDR report key: 10673565 · Received October 13, 2020

    Report

    Report Number
    3005619880-2020-00048
    Event Type
    Injury
    Date Received
    October 13, 2020
    Report Date
    October 13, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE PROXICOR FOR CARDIAC TISSUE REPAIR DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE LOT/SERIAL NUMBER IS UNKNOWN. IT IS ALSO NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20700B) PROVIDED WITH THE FINISHED PROXICOR FOR CARDIAC TISSUE REPAIR DEVICE, STENOSIS, PATCH DEHISCENCE/RUPTURE ARE LISTED AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PROCEDURE AND DEVICE. IN ADDITION, THE IFU FOR THE PROXICOR FOR CARDIAC TISSUE REPAIR DEVICE PROVIDES A WARNING/PRECAUTION THAT THE DEVICE MUST BE SUTURED TO VIABLE NATIVE TISSUE...INDICATING THAT ALL EDGES OF SUTURED ECM PATCH BE MADE TO VIABLE TISSUE WHICH WOULD EXCLUDE . LEAVING A "FREE-EDGE" TO SIMULATE THE COMMISSURAL CLOSURE OF THE VALVE CUSPS. FURTHER, IN THE SUGGESTED INSTRUCTIONS FOR USE (E.G. IMPLANT) IT IS STATED "7. PLACE THE EDGE OF PROXICOR IN CONTACT WITH VIABLE TISSUE". ALTHOUGH THE EXACT CAUSE OF THE REPORTED STENOSIS AND PATCH PROLAPSE (DEHISCENCE/RUPTURE) CANNOT BE CONCLUSIVELY DETERMINED, THESE ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE USE OF A PROXICOR FOR CARDIAC TISSUE REPAIR AND A SURGICAL IMPLANT PROCEDURE. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS ARTICLE / CLINICAL CASE REPORT PUBLISHED IN ANNALS OF THORACIC SURGERY 2017;104:E431-3 TITLED "CALCIFIC DEGENERATION OF CORMATRIX 4 YEARS AFTER BICUSPIDIZATION OF UNICUSPID AORTIC VALVE" WAS REVIEWED. THIS ARTICLE REPORTS A CASE STUDY RELATED TO A 12 YEAR OLD BOY WITH CONGENITAL AORTIC VALVE (AV) STENOSIS TREATED WITH BALLOON VALVULOPLASTY IN INFANCY WHICH HAD PROGRESSED TO SEVERE AV STENOSIS. THE PATIENT UNDERWENT A BICUSPIDIZATION PROCEDURE OF A SEVERELY STENOTIC UNICUSPID AORTIC VALVE WITH CORMATRIX (NOW AZIYO BIOLOGICS) ECM FOR CARDIAC TISSUE REPAIR (MODEL #: CMCV-120-401, LOT #: UNKNOWN) WHICH UPON COMPLETION OF PROCEDURE DEMONSTRATED ACCEPTABLE SURGICAL AND ECHOCARDIOGRAPHIC RESULTS. PATIENT EVALUATED EVERY 3 MONTHS (1ST YEAR) AND 6 MONTHS THEREAFTER (2ND YEAR) SHOWING A STABLE AND WELL-FUNCTIONING AORTIC VALVE WITHOUT ANY CHANGES IN LEAFLET SIZE, INTEGRITY, FUNCTION, OR PROGRESSION OF POSTOPERATIVE MILD INSUFFICIENCY. AT 52.5 MONTHS PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA. ECHOCARDIOGRAPHY SHOWED PATCH PROLAPSE WITH SEVERE AORTIC REGURGITATION, MILD STENOSIS, AND LEFT VENTRICULAR DILATATION. REINTERVENTION WAS INDICATED, AND THE PATIENT UNDERWENT A ROSS PROCEDURE. ATTEMPTS TO CONTACT CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL FOR ANY ADDITIONAL INFORMATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135037 PROXICOR FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS INC. CMCV-120-401

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention