BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 10784410 · Received November 4, 2020

    Report

    Report Number
    3005619880-2020-00093
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 4, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE VASCURE FOR VASCULAR REPAIR DEVICE HISTORY RECORD FOR THE REPORTED COULD NOT BE COMPLETED AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - (B)(4)) PROVIDED WITH THE FINISHED VASCURE FOR VASCULAR REPAIR DEVICE, (PSEUDO) ANEURYSM IS LISTED AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE PROCEDURE AND DEVICE. ALTHOUGH THE EXACT CAUSE OF THE REPORTED ISSUES CANNOT BE CONCLUSIVELY DETERMINED, (PSEUDO) ANEURYSM IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF A VASCURE FOR VASCULAR REPAIR AND A SURGICAL IMPLANT PROCEDURE. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 10/05/2020 BY AN AZIYO SALES REPRESENTATIVE THAT THEY WERE NOTIFIED OF AN ADVERSE EVENT RELATED TO AN IMPLANT OF AN AZIYO VASCURE FOR VASCULAR REPAIR (MODEL #: CMCV-013-609; LOT #: UNKNOWN) PERFORMED IN (B)(6) 2019 (EXACT DATE NOT REPORTED - (B)(6) USED FOR DATE OF IMPLANT FIELD) USED IN CAROTID ENDARTERECTOMY. ON (B)(6) 2020 THE PATIENT RETURNED WITH A SUSPECTED PSEUDOANEURYSM AND UNDERWENT A PROCEDURE TO REMOVE REPAIR. THE SURGEON REPORTED THAT THEY FOUND A BLOW OUT AT THE BASE OF THE PATCH AND A SAMPLE WAS SENT TO PATHOLOGY. ADDITIONAL FOLLOW-UPS WITH PHYSICIAN AND SALES REPRESENTATIVE PROVIDED NO FURTHER INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251997 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS INC. CMCV-013-609 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention