BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 10255874 · Received July 9, 2020

    Report

    Report Number
    3005619880-2020-00038
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    May 23, 2020
    Report Date
    July 9, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005065
    PMA / PMN Number
    K192616
    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 01/29/2020 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. IT IS NOTED THAT THE REPORTED EVENTS DO NOT MEET THE CRITERIA FOR A COMPLAINT, IN THAT THE EVENT WAS PHYSICIAN INDUCED THROUGH INCISION MANIPULATION, HOWEVER AS THE RESULT OF THE EVENT INVOLVED A POCKET REVISION INVOLVING THE CANGAROO ENVELOPE, AN ADVERSE EVENT REPORT IS STILL WARRANTED. ALTHOUGH THE REPORTED EVENT CANNOT BE TRACED SPECIFICALLY TO THE CANGAROO ENVELOPE, POCKET REVISIONS ARE A KNOWN COMPLICATION TO THE SURGICAL IMPLANT PROCEDURE OF A CIED. 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-LRG, LOT #M20A1044) WAS USED WITH A BOSTON SCIENTIFIC CIED (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE PHYSICIAN WAS REMOVING A SCAB FROM THE INCISION LINE WHICH RESULTED IN AN OPENING OF THE INCISION. HENCE, THE PHYSICIAN PERFORMED A POCKET REVISION. THE ENTIRE SYSTEM REMAINED IN SERVICE INCLUDING THE AZIYO CANGAROO ENVELOPE. THERE WERE NO ADDITIONAL PATIENT EFFECTS REPORTED. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 06/09/2020 BY BOSTON SCIENTIFIC, WITH ADDITIONAL DETAILS PROVIDED ON 07/09/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719345 CANGAROO ENVELOPE MESH, SURGICAL, FTM FTM AZIYO BIOLOGICS, INC. CMCV-009-LRG M20A1044 00859389005065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention