BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 15714373 · Received November 2, 2022

    Report

    Report Number
    3005619880-2022-00018
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    June 29, 2022
    Report Date
    November 2, 2022
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPECIFIC CAUSE OF THE PSEUDOANEURYSM CANNOT BE CONCLUSIVELY ESTABLISHED. THE SITE WAS NOT REOPENED AND THE IMPLANT REMAINED IN PLACE. THE PHYSICIAN WAS NOT ABLE TO IDENTIFY IF THE PSEUDOANEURYSM WAS AT THE MARGIN OF THE ORIGINAL IMPLANT AS OPPOSED TO IN THE SAME ARTERIAL SITE. THE ORIGINAL SURGERY ITSELF, WITH THE OPENING OF THE ARTERY AND THE PLACEMENT OF A PATCH, WHICH IS SUTURED TO THE PATIENT'S NATIVE TISSUE, COULD HAVE CONTRIBUTED TO THE EVENT. THE FACT THAT THE PATCH WAS IN PLACE FOR TEN YEARS, IN A HIGH FLOW, HIGH-PRESSURE LOCATION COULD HAVE CONTRIBUTED TO THE FAILURE OF THE PATCH TO COMPLETELY REMODEL OR FOR THE ANASTOMOSIS (SUTURE) TO FAIL OVER TIME. HOWEVER, IT IS MORE LIKELY THAT THIS WAS NOT A PATCH FAILURE, AS THE PATCH SHOULD HAVE BEEN FULLY REMODELED IN THE ENSUING TEN YEARS. "PSEUDOANEURYSM" IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE PATCH AND IS REFLECTED IN THE INSTRUCTIONS FOR USE, DISTRIBUTED WITH THE VASCURE FOR VASCULAR REPAIR DEVICE.

    Description of Event or Problem · 0

    EMAIL RECEIVED FROM SALES REP: "PATIENT PRESENTED 10 YEARS AFTER INITIAL SURGERY [FOR CAROTID REPAIR WITH VASCURE] WITH ASYMPTOMATIC PSEUDOANEURYSM 2.5CM. DURING A MODIFIED TCAR (TRANSCAROTID ARTERY REVASCULARIZATION) PROCEDURE, A STENT WAS PLACED THROUGH A CATHETER; VASCURE PATCH WAS NOT REMOVED." PSEUDOANEURYSM DESCRIBED AS ON THE EDGE OF PATCH AND NOT IN THE MIDDLE. PHYSICIAN STATED THAT HE WAS NOT SURE IT HAD ANYTHING TO DO WITH AZIYO PATCH BUT CONSIDERED THIS "ATYPICAL" AND "CONSISTENT WITH LONG TERM PATCH DATA THAT PATCHES CAN BECOME ANEURYSMIC". PATIENT HAD NO REPORTED COMORBIDITIES AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275618 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET-INTRACARDIAC-DXZ DXZ AZIYO BIOLOGICS, INC. CMCV-013-609 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention