BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 18143012 · Received November 15, 2023

    Report

    Report Number
    3005619880-2023-00002
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    UDI-DI
    00859389005119
    PMA / PMN Number
    K201313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 (B)(6) 2023, SHOWING THAT ALL UNITS WERE QUALITY RELEASED ON (B)(6) 2023 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 ALSO 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 BE NOTED THAT THE PRESENCE OF INFECTION WAS NOT CONFIRMED. ANTIBIOTICS WERE STARTED POST-OPERATIVELY, LIKELY DUE TO THE PATIENT'S ELEVATED TEMPERATURE. WHEN THE DRAINAGE WAS ULTIMATELY CULTURED, CULTURES WERE NEGATIVE. THE PRESENCE OF OTHER SYMPTOMS, SUCH AS COPIOUS AMOUNTS OF PURULENCE, AND THE NEED FOR A WOUND VAC, SUPPORT THE LIKELIHOOD OF INFECTION AS THE SOURCE OF THE EXPLANTATION. THE SPECIFIC CAUSE OF THE POCKET INFECTION CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE PHYSICIAN REPORTED THAT HE BELIEVED THE ICD WAS "DEFINITELY RELATED" TO THE INFECTION AND HE WAS UNSURE IF THE CANGAROO ENVELOPE WAS RELATED.

    Description of Event or Problem · 0

    EMAIL RECEIVED FROM SALES REP WITH ADVERSE EVENT REPORT AS FOLLOWS: POCKET INFECTION. 65-YEAR OLD MALE HAD SUBQ ICD (BOSTON SCIENTIFIC) DEVICE PLACED (B)(6) 2023 USING THE CANGAROO ENVELOPE (CMCV-009-XXL, LOT #M23F1182). PATIENT BECAME FEBRILE WITHIN 24 HOURS AND WAS PLACED ON TWO ANTIBIOTICS POST-OPERATIVELY. ICD AND CANGAROO EXPLANTED (B)(6) 2023 FOR POCKET INFECTION, WITH APPROXIMATELY 500CC OF PUS REMOVED. CULTURES WERE PERFORMED AND RESULTS WERE NEGATIVE. PATIENT RECEIVED A WOUND VAC FOR THE SITE OF THE EXPLANT AND PLAN IS TO SEND PATIENT HOME EVENTUALLY WITH A LIFE VEST. EXPLANTING PHYSICIAN STATED THAT INFECTION WAS "DEFINITELY RELATED" TO THE ICD DEVICE BUT COULD NOT RULE OUT INVOLVEMENT OF THE CANGAROO ENVELOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981780 CANGAROO ENVELOPE MESH, SURGICAL-FTM FTM ELUTIA INC. CMCV-009-XXL M23F1182 00859389005119

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention BOSTON SCIENTIFIC SUBQ ICD