BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 5003424 · Received August 12, 2015

    Report

    Report Number
    3005619880-2015-00043
    Event Type
    Injury
    Date Received
    August 12, 2015
    Report Date
    July 18, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECM TISSUE SAMPLE WAS NOT RETURNED TO CORMATRIX FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON AND STAFF. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. MANUFACTURING RECORDS FOR LOT M15B1054 HAVE BEEN REVIEWED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE ONLY EVENT ASSOCIATED WITH LOT M15B1054 TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE CORMATRIX ECM FOR VASCULAR REPAIR PRODUCT. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT A FEMORAL ENDARTERECTOMY CASE HAD BLED POSTOPERATIVELY. THE ECM PATCH MATERIAL WAS REPORTED NOT TO BE OVER SOAKED BUT THAT THE DOCTOR BASICALLY DIPPED AND WETTED THE PATCH IN SALINE PRIOR TO USE. DEEP SUTURE BITES WERE TAKEN THROUGHOUT ALL LAYERS AND APPEARED "FINE" PRIOR TO CLOSURE. PATIENT LATER RETURNED DUE TO HEMATOMA FORMATION. WHEN THE SITE WAS OPENED, DELAMINATION WAS OBSERVED. ADDITIONAL INFORMATION IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530814 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-011-606 M15B1054

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention