BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX CANGAROO ECM ENVELOPE

    MDR report key: 7806686 · Received August 22, 2018

    Report

    Report Number
    3005619880-2018-00008
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    January 23, 2017
    Report Date
    August 17, 2018
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    FTM
    UDI-DI
    00859389005034
    PMA / PMN Number
    K140306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED ON 8/22/2016 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. ALL STERILIZATION RECORDS, AND BIOBURDEN TESTING INDICATE SUCCESSFUL STERILIZATION PROCESS, AND PASSING LAL AND PRODUCT STERILITY RESULTS ALLOWED THE LOT TO BE RELEASED HAVING MET ALL CRITERIA FOR MANUFACTURING RELEASE. THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THE MANUFACTURING LOT DURING PRODUCTION, STERILIZATION AND FINAL PACKAGING. IN LIEU OF A REQUEST FOR THE OEM SUPPLIER DHR REVIEW, IT IS NOTED THAT AZIYO PROCESSES THE NON-STERILE ECM MATERIALS BY CUTTING, SUTURING, PACKAGING, AND STERILIZING. IN THE IFU (P/N 20266-031314) UNDER THE SECTION, POTENTIAL COMPLICATIONS, IT STATES IN PART, "DEVICE-RELATED COMPLICATIONS ARE POSSIBLE HEMATOMA." THE CAUSE FOR RECURRENT HEMATOMAS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER THE SITE INVESTIGATOR STATES THAT THE EVENT'S PROBABLE CAUSE WAS THERAPEUTIC COUMADIN, ANTICOAGULATION WITH PLATELET DYSFUNCTION AND BLEEDING DIATHESIS.

    Description of Event or Problem · 1

    ORIGINAL INFORMATION RECEIVED ON 1/30/2017: AE#1 - IT WAS REPORTED THAT A CANGAROO ECM ENVELOPE WAS USED ON A (B)(6) WHITE MALE WITH RISK FACTORS OF SYSTEMIC ANTICOAGULANTS, RENAL INSUFFICIENCY AND SMOKER. IMPLANT PROCEDURE WAS ON (B)(6) 2017 AND A PM WAS PLACED. ECM WAS SOAKED IN GENTAMYCIN AND IV ANTIBIOTIC GIVEN PRE-OPERATIVELY. ON (B)(6) 2017 SUBJECT WAS ADMITTED TO THE HOSPITAL FOR THROMBOCYTOPENIA (PAST MEDICAL HISTORY OF THIS) WITH PLATELETS AT 111. HE ALSO WAS NOTED TO HAVE A HEMATOMA AT THIS TIME. IT IS CURRENTLY UNKNOWN IF THE EVENTS ARE RELATED TO THE CORMATRIX DEVICE OR PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 2/1/2017 ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE TWO RECURRENT EVENTS FOR HEMATOMA'S. AE#1 ON (B)(6) 2017 THE PATIENT WAS ADMITTED FOR THROMBOCYTOPENIA AND WAS GIVEN A PLATELET INFUSION. THE SITE INVESTIGATOR STATES THAT THE EVENT'S PROBABLE CAUSE WAS THERAPEUTIC COUMADIN AND ANTICOAGULATION WITH PLATELET DYSFUNCTION. AE#2 ON (B)(6) 2017 THE PATIENT WAS HOSPITALIZED DUE TO RECURRING HEMATOMA AND IT WAS DECIDED THAT THE PATIENT NEEDED A POCKET REVISION AND EXPLORATION. THE ECM POUCH WAS REMOVED AND THE EVENT WAS CONCLUDED BY INVESTIGATOR TO BE POSSIBLY RELATED TO PROCEDURE AND NOT RELATED TO ECM DEVICE, BUT THAT THE PROBABLE CAUSE WAS BLEEDING DIATHESIS. ON 7/20/2018 FOLLOWING AN AUDIT/REVIEW OF SITE CLINICAL FILES, ADDITIONAL INFORMATION WAS IDENTIFIED AS FOLLOWS: AE#1 - EVENT RESOLVED ON (B)(6) 2017 AND THE DESCRIPTION FOR THE EVENT AS RECORDED ON THE CASE REPORT FORM (CRF) CHANGED TO "PATIENT ADMITTED ON (B)(6) 2017 FOR BLEEDING WITH HEMATOMA AND HISTORY OF THROMBOCYTOPENIA. GIVEN A PLATELET INFUSION AND THERAPEUTIC ANTICOAGULATION. PLATELET COUNT = 145. ALSO THE SITE INDICATED THAT THE EVENT WAS "POSSIBLY RELATED" TO THE DEVICE. AE#2 - INFORMATION RECORDED ON THE INITIAL CASE REPORT FORM WAS REVISED TO REFLECT: EVENT WAS "POSSIBLY RELATED" TO THE DEVICE AND PROBABLE CAUSE OF THE EVENT WAS "BLEEDING DIATHESIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647834 CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL FTM AZIYO BIOLOGICS, INC. CMCV-009-MED M16H1209 00859389005034

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention