BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 14285962 · Received May 5, 2022

    Report

    Report Number
    3005619880-2022-00013
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 3, 2022
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. MANUFACTURING REVIEW OF THE REFERENCED LOT NUMBER AND RESPECTIVE DEVICE HISTORY RECORD WAS CONDUCTED ON (B)(6) 2022, SHOWING THAT ALL UNITS WERE QUALITY RELEASED ON (B)(6) 2022 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING THE FINAL PACKAGING. A REQUEST FOR REVIEW FROM THE OEM SUPPLIER OF THE ECM WAS COMPLETED; HOWEVER, NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED POTENTIALLY CONTRIBUTING TO THE REPORTED ISSUE. THE EXACT CAUSE OF THE REPORTED DELAMINATION EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE IFU SUPPLIED WITH THE DEVICE LISTS 'UNDESIRED TISSUE REMODELING, INCLUDING RAPID DEGRADATION OF VASCURE' AS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE VASCURE FOR VASCULAR REPAIR DEVICE AND THE SURGICAL IMPLANT PROCEDURE. THE EXACT CAUSE OF THE HEMATOMA EVENT ALSO CANNOT BE CONCLUSIVELY DETERMINED. IT IS UNKNOWN IF THE HEMATOMA AROSE FROM THE DELAMINATION EVENT. IT COULD ALSO HAVE OCCURRED DUE TO THE PATIENT HAVING HER SURGICAL SITE MANIPULATED TWICE, THE LIKELIHOOD THAT SHE WAS ANTICOAGULATED, AND HER HISTORY OF HYPERTENSION AND DIABETES. HOWEVER, THE IFU SUPPLIED WITH THE DEVICE LISTS 'HEMATOMA' AS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE VASCURE FOR VASCULAR REPAIR DEVICE AND THE SURGICAL IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    AZIYO SALES REP REPORTED THAT PHYSICIAN PLACED AN AZIYO VASCURE FOR VASCULAR REPAIR DEVICE (MODEL CMCV-013-609, LOT M21K1359) TO REPAIR A CAROTID ARTERY. PHYSICIAN REPORTED "PATCH FAILED WITHIN THE SUTURE LINE". HE STATED THAT THE PATCH APPEARED TO "DELAMINATE IN THE CENTER OF THE PATCH". DATE OF IMPLANT REPORTED AS (B)(6) 2022. ON (B)(6)2022, PATIENT HAD A PLACEMENT OF A HEPARIN-BOND COVERED STENT AND (B)(6) 2022 HAD THE DRAINAGE OF A HEMATOMA. THE AZIYO DEVICE REMAINS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407953 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET-INTRACARDIAC DXZ AZIYO BIOLOGICS, INC. CMCV-013-609 M21K1359 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention