BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX CANGAROO ECM ENVELOPE

    MDR report key: 5959452 · Received September 19, 2016

    Report

    Report Number
    3005619880-2016-00025
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    July 29, 2016
    Report Date
    September 19, 2016
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    FTM
    UDI-DI
    00859389005072
    PMA / PMN Number
    K140306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN OFFICE REPORTS ON (B)(6) 2016 THAT INFECTION HAS CLEARED. CORMATRIX HAS COMPLETED A REVIEW OF ALL ECM RAW MATERIALS, MANUFACTURING AND STERILIZATION RECORDS ASSOCIATED WITH LOT M16E1138. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES FOUND DURING THE REVIEW. THE LOT IN QUESTION MET ALL REQUIREMENTS FOR RELEASE. THE CAUSE OF THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED. ATTENDING PHYSICIAN COULD NOT CONFIRM ROOT CAUSE OF INFECTION, HOWEVER PATIENT PRIOR HISTORY OF BACTEREMIA, DRUG ABUSE, AND NUMEROUS DEVICE CHANGE-OUTS AS WELL AS BEING INCARCERATED FOLLOWING DEVICE IMPLANT WITH POTENTIAL HYGIENE, SURROUNDINGS, AND INTERACTION WITH OTHERS BEING CONTRIBUTING FACTORS. IN THE IFU (P/N 20266-031314) UNDER THE SECTION, POTENTIAL COMPLICATIONS, IT STATES IN PART, "DEVICE-RELATED COMPLICATIONS ARE POSSIBLE INFECTION." IN ADDITION UNDER THE SECTION, SUGGESTED INSTRUCTIONS FOR IMPLANTING THE CORMATRIX CANGAROO ECM ENVELOPE, IT STATES IN PART, "INSPECT THE CORMATRIX CANGAROO ECM ENVELOPE PACKAGING/POUCH FOR SIGNS OF DAMAGE. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED." USING ASEPTIC TECHNIQUE TO HANDLE THE DEVICE AT ALL TIMES.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 8/22/2016 THAT A CORMATRIX CANGAROO ECM ENVELOPE WAS USED IN A PROCEDURE ON (B)(6) 2016 ON A YOUNG FEMALE PATIENT THAT HAS HAD SEVERAL PREVIOUS CHANGE-OUTS. THE PATIENT APPEARED 23 DAYS POST-OP WITH PAIN AT THE DEVICE SITE. PATIENT HAD WHAT APPEARED TO BE A STITCH ABCESS AT THE LATERAL CORNER OF INCISION THAT WAS REMOVED AND CLEANSED. PATIENT RETURNED 6 DAYS LATER ((B)(6) 2016) WITH LOCALIZED PAIN AND CONTINUED SWELLING BUT WOUND APPEARED HEALED. ON (B)(6) 2016 PATIENT PRESENTED WITH REDNESS, SWELLING, AND PUS ON THE BANDAGES THAT WERE REMOVED. THE WOUND WAS WARM TO THE TOUCH, BUT NO REPORTED FEVERS. PATIENT STARTED ON ORAL BACTRIM (3X/DAY). ON (B)(6) 2016 ALL SIGNS OF POTENTIAL INFECTION HAD CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611396 CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL FTM CORMATRIX CARDIOVASCULAR, INC. CMCV-009-XLG M16E1138 00859389005072

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention