BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANGAROO ENVELOPE

    MDR report key: 20545548 · Received October 28, 2024

    Report

    Report Number
    3005619880-2024-00002
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    April 1, 2024
    Report Date
    October 28, 2024
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    PMA / PMN Number
    K201313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20662C) PROVIDED WITH THE FINISHED KANGAROO ENVELOPE DEVICE, INFECTION AND INFLAMMATION ARE LISTED AS A POTENTIAL COMPLICATIONS ASSOCIATED WITH THIS PROCEDURE AND DEVICE USAGE. WHILE THE CANGAROO DEVICE WAS USED CONSISTENT WITH IT INDICATION, THE CANGAROO ENVELOPE IS NOT INTENDED TO BE USED IN COMBINATION WITH A SYNTHETIC SUBSTRATE AND NOT MAINTAINING CONTACT WITH VIABLE TISSUE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME, SHOULD ELUTIA RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS CASE STUDY REPORT PUBLISHED IN HEART RHYTHM SOCIETY TITLED "SUCCESSFUL EXTRAVASCULAR IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IMPLANTATION IN A PATIENT WITH RECURRENT TRANSVENOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR EROSION" WAS REVIEWED. THE CASE STUDY REPORTS ON A 63 YR. OLD MALE PATIENT WITH NONISCHEMIC CARDIOMYOPATHY HAVING A PRIOR IMPLANT OF A SINGLE-CHAMBER TRANSVENOUS ICD UTILIZING AN ANTIBIOTIC POUCH RESULTING IN DEHISCENCE OF SURGICAL SITE AND EROSION AT 7 MONTHS FOLLOW-UP. A SECOND IMPLANT PERFORMED ON CONTRALATERAL PREFECTORAL SPACE USING A DUAL-CHAMBER ICD WITH AN ANTIBIOTIC ENVELOPE COMBINED WITH A KANGAROO ENVELOPE (MODEL # / LOT # UNKNOWN). NINE DAYS POST-OP PATIENT PRESENTED WITH PROTRUDING SUTURE FROM INCISION AND PURULENT DRAINAGE. PATIENT TREATED WITH ANTIBIOTICS AND STERI-STRIPS USED TO RE-APPROXIMATE SURGICAL SITE. AT 25 DAYS POST-OP PATIENT PRESENTED WITH VISIBLE HARDWARE THROUGH INCISIONAL DEHISCENCE. THE DEVICE WAS REMOVED WITHOUT COMPLICATION AND PATIENT REFERRED FOR EXTRAVASCULAR ICD (E.G., EVICD) WHICH WAS PERFORMED SUCCESSFULLY. THE PATIENT HAS HAD NO SIGNS OF INFECTION OR EROSION AFTER > 18 MONTHS OF FOLLOW-UP. FOLLOW-UP ATTEMPTS TO CONTACT THE CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL AND NO DETAILS HAVE BEEN PROVIDED REGARDING SPECIFIC PRODUCT USED AND CORRESPONDING LOT NUMBERS. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965229 CANGAROO ENVELOPE MESH, SURGICAL FTM ELUTIA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention