BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXICOR CARDIAC TISSUE REPAIR

    MDR report key: 12096814 · Received June 30, 2021

    Report

    Report Number
    3005619880-2021-00021
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    October 1, 2020
    Report Date
    June 30, 2021
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE MODEL NUMBER/LOT NUMBER WERE NOT PROVIDED. THE CORMATRIX (NOW AZIYO BIOLOGICS) PROXICOR FOR CARDIAC TISSUE REPAIR WAS PLACED TO RECONSTRUCT AND REINFORCE THE MITRAL-AORTIC INTERVALVULAR FIBROSA (AN ANATOMICAL WALL) DURING A PREVIOUS SURGERY. THE AUTHORS STATE THAT BIOLOGICAL GLUE WAS USED ON THE SUTURE LINE TO ARREST BLEEDING. INSTRUCTIONS FOR USE (ART-20706A) PROVIDED WITH THE DEVICE STATE UNDER THE SECTION "WARNINGS AND PRECAUTIONS", THAT THE AZIYO DEVICE IS NOT RECOMMENDED TO BE USED WITH GLUE CONTAINING GLUTARALDEHYDE. IN ADDITION, THE INSTRUCTIONS FOR USE PROVIDED WITH THE PROXICOR FOR CARDIAC TISSUE REPAIR (ART-20706A) IDENTIFIES AS POTENTIAL COMPLICATIONS - DEHISCENCE AND PSEUDOANEURYSM.

    Description of Event or Problem · 1

    DURING POST-MARKET SURVEILLANCE, ARTICLE ENTITLED "MULTIMODALITY IMAGING IN THE EVALUATION OF ASCENDING AORTIC PSEUDOANEURYSMS TO GUIDE COMPLEX SURGICAL MANAGEMENT", CASE: CARDIOVASCULAR IMAGING CASE REPORTS, OCTOBER 2020, WAS REVIEWED AND SUMMARIZED AS FOLLOWS: (B)(6)-YEAR-OLD MAN UNDERWENT THREE CARDIAC SURGERIES WITH SEVERAL GRAFTS AND VALVE REPLACEMENT PROCEDURES, ONE OF WHICH UTILIZED A "CORMATRIX PATCH". WHILE THE SPECIFIC CORMATRIX (NOW AZIYO BIOLOGICS) DEVICE WAS NOT SPECIFIED, IT WAS LIKELY A PROXICOR FOR CARDIAC TISSUE REPAIR (MODEL #: UNKNOWN, LOT #: UNKNOWN); SELECTED DUE TO TYPE OF REPAIR PERFORMED - RECONSTRUCTION OF THE MITRAL-AORTIC INTERVALVULAR FIBROSA. THREE YEARS LATER, THE PATIENT DEVELOPED DYSPNEA AND CHEST PAIN. THE PATIENT WAS DIAGNOSED WITH AORTIC ROOT PSEUDOANEURYSM AT THE GRAFT SITE AS WELL A PSEUDOANEURYSM AT THE AORTIC VALVE ANASTOMOTIC SITE. UPON REOPERATION, THE PATCH USED TO RECONSTRUCT THE INTERVALVULAR FIBROSA DURING THE PATIENT'S PREVIOUS SURGERY WAS FOUND TO HAVE NECROSED, CAUSING DEHISCENCE OF THE PATCH. THIS LED TO A PSEUDOANEURYSM WHICH AFFECTED VALVE FUNCTION AND LED TO PERFUSION COMPROMISE. THERE WERE NO SIGNS OF ACTIVE INFECTION. THE PATCH WAS EXCISED AND THE DESCENDING AORTA AND VALVE WERE AGAIN REPLACED, AND THE PATIENT'S POST-OP COURSE WAS UNEVENTFUL. ATTEMPTS TO CONTACT CORRESPONDING AUTHOR OF PUBLICATION FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED RELATED TO THIS EVENT, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989767 PROXICOR CARDIAC TISSUE REPAIR PATCH, PLEDGET AND INTRACARDIAC-DXZ DXZ AZIYO BIOLOGICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention