BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 9404964 · Received December 3, 2019

    Report

    Report Number
    3005619880-2019-00013
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 3, 2019
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 06/11/2019 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 CONFIRMED THAT "ALL DEVICES MET SPECIFICATION." THE INSTRUCTIONS FOR USE SUPPLIED WITH THE VASCULAR PRODUCT (ART-20708A) WAS REVIEWED. UNDER THE SECTION 'POTENTIAL COMPLICATIONS', IT STATES IN PART: "THE FOLLOWING COMPLICATIONS ARE POSSIBLE. IF ANY OF THESE CONDITIONS OCCUR, THE VASCURE SHOULD BE REMOVED. INFECTION". THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED BUT IS A KNOWN POTENTIAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAROTID ENDARTERECTOMY WAS PERFORMED ON (B)(6) 2019. THE VASCURE WAS SOAKED FOR LESS THAN ONE MINUTE IN SALINE AND WAS SEWN TO PATIENT TISSUE. THE PATIENT REQUIRED SURGICAL INTERVENTION AND WAS RE-OPERATED ON (B)(6) 2019 TO RESOLVE WHAT WAS DESCRIBED AS A "BLOW OUT OF THE AZIYO CAROTID PATCH". THE PROBABLE CAUSE OF THE EVENT PER THE PHYSICIAN WAS INFECTION; THE PATIENT TESTED POSITIVE FOR GRAM NEGATIVE INFECTION (STAPH SCHLEIFERI AND STAPH HOMINIS). THE VASCURE PRODUCT WAS EXPLANTED AND REPLACED WITH A BOVINE PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198289 VASCURE FOR VASCULAR REPAIR VASCURE FOR VASCULAR REPAIR DXZ AZIYO BIOLOGICS, INC. CMCV-014-609 M19F1240 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention