BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 10744162 · Received October 27, 2020

    Report

    Report Number
    3005619880-2020-00055
    Event Type
    Injury
    Date Received
    October 27, 2020
    Report Date
    October 27, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    DXZ
    UDI-DI
    00859389005089
    PMA / PMN Number
    K111187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CORMATRIX ECM FOR CAROTID REPAIR DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED. IT IS NOTED THAT THE USAGE OF THE CORMATRIX ECM FOR CAROTID REPAIR, NOW VASCURE FOR CAROTID REPAIR FOR FORMING A TUBULAR GRAFT AND USAGE FOR ARTERIOVENOUS FISTULA IS AN UNAPPROVED, OFF-LABEL USAGE. SHOULD THE DEVICE HAVE BEEN USED PER APPROVED INDICATIONS, THE INSTRUCTIONS FOR USE (IFU - ART-20702B) PROVIDED WITH THE FINISHED CORMATRIX ECM FOR CAROTID REPAIR DEVICE LISTS STENOSIS AND THROMBOSIS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PROCEDURE AND DEVICE. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS PROSPECTIVE PILOT CASE STUDY REPORT PUBLISHED IN THE JOURNAL OF VASCULAR ACCESS 1-7. 2019 TITLED "USING CORMATRIX FOR PARTIAL AND COMPLETE (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS IN HAEMODIALYSIS PATIENTS: (RE)CONSTRUCTION OF ARTERIOVENOUS FISTULAS WITH CORMATRIX" WAS REVIEWED. THIS ARTICLE PROVIDES THE RESULTS OF SIX (6) PATIENTS WHO UNDERWENT SURGERY BETWEEN MAY 2016 AND JULY 2018 FOR VASCULAR ACCESS RECONSTRUCTION DUE TO THROMBOSIS OF UNSALVAGEABLE ARTERIOVENOUS FISTULAS, PATIENTS WITH HIGH-FLOW ARTERIOVENOUS FISTULAS AND PATIENTS WITH MICROVASCULATURE IN WHICH AUTOLOGOUS ARTERIOVENOUS FISTULAS DID NOT MATURE. THIS REPORT IS FOCUSED ON PATIENT #1 (PER PUBLICATION TABLE 1: PATIENT DEMOGRAPHICS) WHERE A 30 YR. OLD MALE WITH ANEURISMATIC RADIOCEPHALIC ARTERIOVENOUS FISTULA (AVF) IN THE RIGHT FOREARM WITH THROMBOSED OUTFLOW FROM ANEURYSMS. THE SURGEON UTILIZED A 2CM X 10CM CORMATRIX ECM FOR CAROTID REPAIR (NOW AZIYO BIOLOGICS) MODEL # CMCV-072-606; LOT #: UNKNOWN OFF-LABEL TO CREATE AN 8CM (6MM DIAMETER) TUBULAR BRIDGE GRAFT BETWEEN LATERAL CEPHALIC VEIN AND ANTEBRACHIAL CEPHALIC VEIN. AT 7 WEEKS POST-OP, STENOSIS OF THE CORMATRIX VENOUS ANASTOMOSIS AND AVF THROMBOSIS RESULTING IN A PERCUTANEOUS TEA + PTA. AT 4 MONTHS POST-OP, STENOSIS OF CORMATRIX VENOUS ANASTOMOSIS RESULTING IN A STEPPED PTA BEING PERFORMED. GRAFT REMAINED IMPLANTED THROUGH ARTICLE FOLLOW-UP PERIOD OF 26 MONTHS. ATTEMPTS TO CONTACT CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL FOR ANY ADDITIONAL INFORMATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207913 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET AND INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS INC. CMCV-072-606 00859389005089

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention