BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECM FOR VASCULAR REPAIR

    MDR report key: 8041697 · Received November 6, 2018

    Report

    Report Number
    3005619880-2018-00011
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 5, 2018
    Report Date
    November 6, 2018
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR EVALUATION. A REVIEW OF THE COMPLAINT LOG SHOWS THAT THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE REPORTED LOT NUMBER. MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED ON (B)(6) 2018 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THE EXACT ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT CAN BE NOTED THAT THE ECM DEVICE WAS PLACED ON A WET LAP FOR APPROXIMATELY 5-7 MINUTES. THE CONDITION OF THE WET LAP AND HOW MUCH SOLUTION THE ECM DEVICE WAS EXPOSED TO WHILE ON THE WET LAP IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED THAT AN ECM FOR VASCULAR REPAIR DEVICE WAS IMPLANTED ON A FEMALE PATIENT DURING A COMMON FEMORAL ENDARTERECTOMY. THE ECM WAS SOAKED IN SALINE FOR 1 MINUTE AND 24 SECONDS, THEN PLACED ON WET LAP FOR APPROXIMATELY 5-7 MINUTES. AFTER THE CASE WAS COMPLETE, THE PHYSICIAN INFORMED THE AZIYO TECHNICAL SALES REPRESENTATIVE THAT WHILE THE ECM WORKED GREAT, A CORNER OF THE PRODUCT HAD DELAMINATED. THE PHYSICIAN STATED THAT HE HAD SEWN THROUGH ALL OF THE ECM LAYERS AND PUT AN EXTRA STITCH IN THE CORNER. THE ECM WAS SUTURED TO THE PATIENT'S TISSUE AND NO ADHESIVE AGENTS WERE USED. THE PHYSICIAN ALSO WAITED EXTRA TIME TO MAKE SURE THERE WAS NO BLEEDING AT THE CORNER OF THE PRODUCT. THE PHYSICIAN SAID HE WAS NOT CONCERNED ABOUT THE PERFORMANCE OF THE ECM. ACCORDING TO THE PHYSICIAN, THE EVENT WAS NOT RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE ECM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882735 ECM FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ AZIYO BIOLOGICS, INC. CMCV-013-609 M18K1258 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention