BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 18143126 · Received November 15, 2023

    Report

    Report Number
    3005619880-2023-00003
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ELUTIA INC
    Product Code
    FTM
    UDI-DI
    00859389005034
    PMA / PMN Number
    K201313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 10OCT2023, SHOWING THAT ALL UNITS WERE QUALITY RELEASED ON 17JUL2023 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING THE FINAL PACKAGING. STERILE SUBASSEMBLY LOT WAS ALSO REVIEWED FOR POTENTIAL ISSUES IMPACTING THE QUALITY OF THIS PRODUCT. THIS SUBASSEMBLY LOT WAS RELEASED TO COMPONENT INVENTORY, 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 ELUTIA PROCESSES THE NON-STERILE ENVELOPE MATERIALS BY CUTTING, SUTURING, PACKAGING, AND STERILIZING. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20828A) PROVIDED WITH THE FINISHED CANGAROO ENVELOPE DEVICE, "INFECTION" IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THIS DEVICE AND THE SURGICAL PROCEDURE TO IMPLANT IT. IT SHOULD ALSO BE NOTED THAT THE PATIENT WAS INITIALLY REPORTED TO HAVE A HEMATOMA EVENT. HOWEVER, WITH THE CONFIRMATION OF INFECTION, THIS EVENT WAS RE-CATEGORIZED AS A POCKET INFECTION. INTERVENTION INCLUDED DRAINAGE IN AN OFFICE SETTING AND THE INITIATION OF ORAL ANTIBIOTICS. DRAINAGE CULTURE RESULTS WERE POSITIVE FOR BOTH ENTEROCOCCUS AND E. COLI. THE SPECIFIC CAUSE OF THE REPORTED POCKET INFECTION CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    EMAIL FROM SALES REP WITH ADVERSE EVENT REPORT AS FOLLOWS: POCKET INFECTION. PATIENT HAD NEW BIV PACEMAKER PLACED ON (B)(6) 2023 WITH CANGAROO DEVICE (MODEL # CMCV-009-MED, LOT #M23G1206). ON (B)(6) 2023, PATIENT WAS SEEN IN OFFICE AND NOTED TO HAVE A POCKET HEMATOMA. FLUID FROM HEMATOMA WAS DRAINED AND CULTURED, WITH RESULTS POSITIVE FOR ENTEROCOCCUS AND E. COLI. PATIENT STARTED ON ANTIBIOTICS AND SENT HOME. DOCTOR REPORTED ON (B)(6) 2023 THAT PATIENT'S WOUND WAS GETTING WORSE AND HE PLANNED HOSPITAL ADMISSION FOLLOWING UPCOMING OFFICE VISIT. EVENT REPORTED AS "POSSIBLY RELATED" TO CANGAROO ENVELOPE AS WELL AS THE PROCEDURE TO IMPLANT IT. PHYSICIAN STATED CAUSE MAY BE RELATED TO SURGICAL TECHNIQUE AS HE HAD A SECOND PATIENT (WITHOUT CANGAROO DEVICE) WHO DEVELOPED INFECTION WITH THE SAME BACTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320983 CANGAROO ENVELOPE MESH, SURGICAL-FTM FTM ELUTIA INC CMCV-009-MED M23G1206 00859389005034

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention BIV PACEMAKER