BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO

    MDR report key: 12568418 · Received October 4, 2021

    Report

    Report Number
    3005619880-2021-00032
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 4, 2021
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005065
    PMA / PMN Number
    K201313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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 14SEP2021, SHOWING THAT ALL UNITS WERE QUALITY RELEASED ON 07OCT2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NONCONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING THE FINAL PACKAGING. STERILE SUBASSEMBLY LOT M19H1356 (PRT-20679-03) WAS ALSO REVIEWED FOR POTENTIAL ISSUES IMPACTING THE QUALITY OF THIS PRODUCT. THIS SUBASSEMBLY LOT WAS RELEASED TO COMPONENT INVENTORY ON 09SEP2019 HAVING MET ALL QUALITY REQUIREMENTS INCLUDING PRODUCT STERILITY TESTING FOLLOWING EO STERILIZATION, AS WELL AS INTERNAL BIOBURDEN AND PRODUCT PYROGEN (LAL) TESTING REQUIREMENTS. IN LIEU OF A REQUEST FOR THE OEM SUPPLIER FOR A DHR REVIEW OF THE ECM MATERIAL LOTS, IT IS NOTED THAT AZIYO PROCESSES THE NONSTERILE ENVELOPE MATERIALS BY CUTTING, SUTURING, PACKAGING, AND STERILIZING. IT IS ALSO NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20662C) PROVIDED WITH THE FINISHED CANGAROO ENVELOPE DEVICE, INFECTION IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THIS PROCEDURE AND DEVICE USAGE.

    Description of Event or Problem · 0

    ON (B)(6) 2021, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A BIVENTRICULAR PACEMAKER (BIV) IMPLANTED ON (B)(6) 2021 AND AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT NUMBER M19L1435) PRESENTED WITH POCKET INFECTION. THE AZIYO DEVICE WAS EXPLANTED AS PART OF THE REMOVAL OF THE ENTIRE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) SYSTEM ON (B)(6) 2021. PATIENT WAS TREATED WITH IV ANTIBIOTICS AND HAD A NEW DEVICE WITH AZIYO ENVELOPE REIMPLANTED ON (B)(6) 2021. PATIENT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469255 CANGAROO MESH, SURGICAL-FTM FTM AZIYO BIOLOGICS, INC. CMCV-009-LRG M19L1435 00859389005065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention