BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10861895 · Received November 18, 2020

    Report

    Report Number
    3005619880-2020-00095
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    August 7, 2020
    Report Date
    November 18, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    FTM
    UDI-DI
    00859389005034
    PMA / PMN Number
    K192616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 04/17/2020 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 ALLOWING 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 INCLUDING CUTTING, SUTURING, PACKAGING AND STERILIZING THE PRODUCT. THE REASON FOR THE EXPLANTATION OF THE AZIYO DEVICE IS WAS RELATED TO A TUNING ISSUE WITH THE IMPLANTED CIED AND DEVICE LEADS RESULTING IN HIGH PACING THRESHOLDS WHICH WOULD POTENTIALLY DECREASE BATTERY LIFE. A REPLACEMENT DEVICE AND CANGAROO ENVELOPE WERE IMPLANTED FOLLOWING REMOVAL. DEVICE TUNING ISSUES ARE A RECOGNIZED PROCEDURAL COMPLICATION ASSOCIATED WITH CIED IMPLANTATION, AND NOT ASSOCIATED WITH USAGE OF THE CANGAROO ENVELOPE. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, 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-MED LOT #M20D1137) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020 THE DEVICE AND CANGAROO POUCH WERE EXPLANTED DUE TO A LEAD REVISION PROCEDURE REQUIRED DUE TO HIGH PACING THRESHOLDS. A NEW DEVICE AND CANGAROO ENVELOPE WERE IMPLANTED. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON 10/22/2020 AND FURTHER INFORMATION RECEIVED ON 11/18/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326328 CANGAROO ENVELOPE MESH, SURGICAL - FTM FTM AZIYO BIOLOGICS INC. CMCV-009-MED M20D1137 00859389005034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BSC CIED (MODEL# / SERIAL# - UNKNOWN)