BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR CAROTID REPAIR

    MDR report key: 20107947 · Received August 30, 2024

    Report

    Report Number
    3005619880-2024-00001
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ELUTIA INC.
    Product Code
    DXZ
    PMA / PMN Number
    K111187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. MANUFACTURING REVIEW OF THE VASCURE FOR CAROTID REPAIR DEVICE HISTORY RECORD WAS COMPLETED RESULTING IN NO QUALITY ISSUES IDENTIFIED DURING PROCESSING OF THE LOT. ADDITIONALLY, THE SUBCONTRACTOR WAS ASKED TO PERFORM AN EVALUTION OF THE MANUFACTURING DEVICE HISTORY RECORDS, RESULTING IN NO QUALITY ISSUES IDENTIFIED DURING THEIR MANUFACTURING PROCESS. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE FINISHED VASCURE FOR CAROTID REPAIR DEVICE, PSEUDOANEURYSM AND RUPTURE ARE IDENTIFIED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH CAROTID ARTERY SURGICAL PROCEDURES AND DEVICE USAGE. THE ADDITIONAL INFORMATION PROVIDED BY THE SURGEON IMPLIES THAT THE PATCH RUPTURED DUE TO PSEUDOANURYSM APPROXIMATELY THREE MONTHS AFTER THE INITIAL SURGERY AND IMPLANT OF THE VASCURE FOR CAROTID REPAIR DEVICE. THE PHSYCIAN ALSO STATES THAT THE EVENT WAS POSSIBLY RELATED TO THE PATIENT'S INTENSE COUGH AFTER THE INITIAL PROCEDURE; THEREFORE, IT CANNOT BE DETERMINED IF THE DEVICE ALONE WAS THE CAUSE OF THE ADVERSE EVENT. NO OTHER DETAILS ARE AVAILABLE, SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    EMAIL RECEIVED BY QUALITY ASSURANCE FROM USER FACILITY STATING THAT ON (B)(6) 2024 PATIENT UNDERWENT A CAROTID ENDARTERECTOMY FOR SEVERE LEFT INTERNAL CAROTID ARTERY STENOSIS USING THE AZIYO VASCURE FOR CAROTID REPAIR (MODEL #CMCV-072-606; LOT #M23L1352). PHYSICIAN REPORTS THAT THE OPERATION WAS STRAIGHTFORWARD, AND THE PATIENT'S POSTOPERATIVE RECOVERY WAS UNEVENTFUL. ON (B)(6) 2024, PATIENT PRESENTED WITH A PAINFUL, PULSATILE LEFT NECK MASS THAT HAD APPEARED 3 DAYS EARLIER. COMPUTED TOMOGRAPHY REVEALED A LEFT CAROTID PSEUDOANEURYSM CAUSED BY PATCH RUPTURE. PATIENT UNDERWENT URGENT CAROTID RECONSTRUCTION USING SAPHENOUS VEIN PATCH, THE PATIENT'S RECOVERY WAS UNCOMPLICATED, AND HE WAS DISCHARGED ON POSTOPERATIVE DAY 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911384 VASCURE FOR CAROTID REPAIR PATCH, PLEDGET-INTRACARDIAC DXZ ELUTIA INC. CMCV-072-606 M23L1352

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention