BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10255877 · Received July 9, 2020

    Report

    Report Number
    3005619880-2020-00037
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 9, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005065
    PMA / PMN Number
    K182255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CANGAROO ENVELOPE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL PACKAGED AND LABELED UNITS WERE QUALITY RELEASED TO DISTRIBUTION ON (B)(6) 2019 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. ALL STERILIZATION PROCESSING RECORDS AND BIOBURDEN TESTING INDICATE A SUCCESSFUL STERILIZATION CYCLE AND PASSING RESULTS OF PRODUCT LAL AND STERILITY SAMPLES ALLOWED THE SUBASSEMBLY LOT TO BE RELEASED FOR FURTHER PACKAGING AND LABELING HAVING MET ALL CRITERIA FOR RELEASE. THERE WERE NO NON-CONFORMANCES DURING MANUFACTURING OR STERILIZATION POTENTIALLY IMPACTING THE FINAL ACCEPTANCE OF THIS MANUFACTURING LOT. IN LIEU OF A REQUEST FOR THE OEM SUPPLIER DHR REVIEW, IT IS NOTED THAT AZIYO PROCESSES THE NON-STERILE ENVELOPE MATERIALS BY CUTTING, SUTURING, PACKAGING AND STERILIZING THE PRODUCT. IT IS ALSO NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20662) PROVIDED WITH THE FINISHED CANGAROO ENVELOPE DEVICE, INFECTION IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE PROCEDURE AND DEVICE. ALTHOUGH THE EXACT CAUSE OF THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED, INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF A CANGAROO ENVELOPE AND A SURGICAL IMPLANT PROCEDURE. NO ADDITIONAL DETAILS ARE ANTICIPATED WITH THIS EVENT, SHOULD AZIYO RECEIVE ANY MOR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT #M19M1492) WAS USED WITH A BOSTON SCIENTIFIC PULSE GENERATOR (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. PATIENT DEVELOPED AN INFECTION WITH SEPSIS AND HAD HIS PULSE GENERATOR AND LEADS EXPLANTED ON (B)(6) 2020. THE EXTRACTION INCLUDED THE AZIYO ENVELOPE. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON (B)(6) 2020 WITH ADDITIONAL DETAIL PROVIDED (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719358 CANGAROO ENVELOPE MESH, SURGICAL - FTM FTM AZIYO BIOLOGICS, INC. CMCV-009-LRG M19M1492 00859389005065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention