BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 18144317 · Received November 15, 2023

    Report

    Report Number
    3005619880-2023-00004
    Event Type
    Injury
    Date Received
    November 15, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ELUTIA INC
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. MANUFACTURING REVIEW OF THE VASCURE FOR VASCULAR REPAIR DEVICE HISTORY RECORD FOR THE REPORTED EVENT COULD NOT BE COMPLETED, AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE FINISHED VASCURE FOR VASCULAR REPAIR DEVICE, HEMATOMA AND PATCH DEHISCENCE/ RUPTURE (DETERIORATION) ARE LISTED AS POTENTIAL COMPLICATIONS ASSOCIATED WITH AN ENDARTERECTOMY PROCEDURE AND DEVICE USAGE. THE ADDITIONAL INFORMATION PROVIDED BY THE SURGEON IMPLIES THAT THE PATCH DISSOLVED AND DID NOT REPAIR THE DEFECT. "HEMATOMA" WAS THE ORIGINAL DIAGNOSIS, INDICATING THAT THERE WAS BLEEDING AT THE SITE OF THE PATCH. THE SOURCE OF THE BLEEDING CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE SURGEON INDICATED THAT THE PATCH WAS HYDRATED IN HEPARINIZED SALINE PRIOR TO IMPLANTATION (NOT INDICATED IN THE IFU). THIS COULD HAVE HAD AN IMPACT ON THE INTEGRITY OF THE PATCH ITSELF. IT IS ALSO LIKELY THE PATIENT WAS PLACED ON ANTICOAGULATION THERAPY FOR THE UNDERLYING CONDITION THAT REQUIRED THE ENDARTERECTOMY, MAKING THE DEVELOPMENT OF A POST-OP HEMATOMA MORE LIKELY THAN A PATIENT WHO WAS NOT ON ANTICOAGULANTS.

    Description of Event or Problem · 0

    REPORT FROM BUSINESS PARTNER REGARDING ADVERSE EVENT DESCRIBED AS "PATCH BLEW OUT 5 WEEKS AFTER A CAROTID ENDARTERECTOMY." PATIENT HAD BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR (MODEL # CMCV-014-609, LOT #UNKNOWN). EVENT FAILURE REPORTED AS DEVICE-RELATED LARGE HEMATOMA REQUIRING REPAIR BY CAROTID BYPASS. DATE REPORT RECEIVED BY PARTNER 10OCT2023, AND FORWARDED TO AZIYO/ELUTIA ON 11OCT2023 - ACTUAL DATE OF EVENT NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE UPDATED IF MORE INFORMATION IS RECEIVED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162657 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET-INTRACARDIAC-DXZ DXZ ELUTIA INC CMCV-014-609 UNKNOWN 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention