BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 9321242 · Received November 14, 2019

    Report

    Report Number
    3005619880-2019-00012
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    July 24, 2019
    Report Date
    November 14, 2019
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED ON 05/08/2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING PRODUCTION AND FINAL PACKAGING. THE OEM SUPPLIER REVIEWED THE SUB-LOTS ASSOCIATED WITH THE REPORTED LOT AND CONFIRMS THAT "ALL DEVICES MET SPECIFICATION." THE INSTRUCTIONS FOR USE WITH THE VASCULAR PRODUCT (ART-20708A) WAS REVIEWED. UNDER THE SECTION POTENTIAL COMPLICATION, IT STATES: " THE FOLLOWING COMPLICATIONS ARE POSSIBLE. IF ANY OF THESE CONDITIONS OCCUR, THE VASCURE SHOULD BE REMOVED. HEMATOMA, UNDESIRED TISSUE REMODELING (E.G., POOR TISSUE INTEGRATION, EXCESSIVE SCAR TISSUE FORMATION, OR RAPID DEGRADATION OF VASCURE)" THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED BUT ARE KNOWN POTENTIAL COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAROTID ENDARTERECTOMY WAS PERFORMED ON A MALE PATIENT ON (B)(6) 2019. THE VASCURE WAS SOAKED FOR LESS THAN ONE MINUTE IN SALINE AND WAS SEWN WITH A 6-0 PROLENE TO THE PATIENT'S TISSUE. IT WAS STATED THAT "PATIENT DISCHARGED HOME (B)(6) 2019 HAD DISCOMFORT IN NECK WITH HEMATOMA, RE-ADMITTED (B)(6) 2019. TAKEN TO SURGERY WHERE ECM PATCH HAD "SLOUGHED" AWAY WHERE SUTURE WOULDN'T HOLD TO VASCURE. RE-OPERATION WHERE VEIN PATCH WAS SEWN INTO PLACE AFTER ECM WAS EXPLANTED. PATIENT RETURNED TO OPERATING ROOM WHERE VEIN PATCH WAS EXPLANTED AND A DACRON PATCH WAS SEWN IN TO REPLACE." IT CAN BE NOTED THAT THE PATIENT HAD UNCONTROLLED HYPERTENSION. PROBABLE CAUSE OF THE EVENT WAS STATED AS "UNSURE". THE PATIENT WAS DISCHARGED ON (B)(6) 2019 AND IS RECOVERING AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119747 VASCURE FOR VASCULAR REPAIR VASCURE FOR VASCULAR REPAIR DXZ AZIYO BIOLOGICS, INC. CMCV-014-609 M19E1179 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention