BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 9315072 · Received November 13, 2019

    Report

    Report Number
    3005619880-2019-00011
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    September 14, 2019
    Report Date
    November 12, 2019
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS ALL UNITS WERE QUALITY RELEASED ON 07 MAY 2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING PRODUCTION AND FINAL PACKAGING. OEM SUPPLIER REVIEWED THE SUB-LOTS ASSOCIATED WITH THE REPORTED LOT AND CONFIRMED THAT "ALL DEVICES MET SPECIFICATION". THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED. THE PROBABLE CAUSE OF THE EVENT IS PREVIOUS INFECTION AND THE DEVICE MAY NOT HAVE BEEN SEWN TO VIABLE TISSUE.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE OR FOR A RE-DO ON AN INFECTED ENDARTERECTOMY. BOVINE PATCH WAS EXPLANTED AND REPLACED USING AZIYO VASCURE ON (B)(6) 2019. BOTH THE BOVINE PATCH, FEMORAL ARTERY, BYPASS GRAPH AND SURROUNDING TISSUE OF THE GROIN WERE BADLY INFECTED. IT WAS REPORTED THAT ON (B)(6) 2019 THE VASCURE PATCH HAD DISINTEGRATED/DISSOLVED, FEMORAL ARTERY HAD THROMBOSED AND INFECTION WAS PRESENT. SERRATIA MARCESCENS WAS THE CONFIRMED PATHOGEN. THE SERRATIA MARCESCENS PATHOGEN HAS BEEN PRESENT MULTIPLE TIMES (THE PATIENT WAS GROWING IT WHEN THE VASCURE WAS IMPLANTED) WITH THIS PATIENT AND THE PATIENT'S PREVIOUS HISTORY. THE PHYSICIAN WAS NOT SURE IF THE VASCURE PATCH WAS SEWN TO VIABLE TISSUE AND THAT THIS COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE PATIENT WAS REPORTED AS STABLE AND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110056 VASCURE FOR VASCULAR REPAIR VASCURE FOR VASCULAR REPAIR DXZ AZIYO BIOLOGICS, INC. CMCV-013-609 M19E1184 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention