BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCU-GUARD

    MDR report key: 379308 · Received February 27, 2002

    Report

    Report Number
    2183620-2002-00004
    Event Type
    Injury
    Date Received
    February 27, 2002
    Date of Event
    March 22, 2002
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001 PATIENT UNDERWENT REPAIR OF OCCLUDED CAROTID ARTERY WITH IMPLANTATION OF VASCU-GUARD PERIPHERAL VASCULAR PATCH. IN LATE NOVEMBER 2001 (DATE UNKNOWN), PATCH TORE AND WAS REPAIRED. ONE MONTH LATER PATIENT EXPERIENCED RIGHT NECK HEMATOMA WITH ACTIVE BLEEDING. SURGEON STATED VASCU-GUARD PATCH HAD TORN AND REQUIRED SUTURE REPAIR WITH A COATING OF FIBRIN GLUE. IN THE PROCESS PATIENT SUFFERED CVA (CEREBRAL VASCULAR ACCIEDENT) AND IS CURRENTLY UNDERGOING REHABILITATION FOR STROKE.

    Description of Event or Problem · 1

    ON 3/22/2002 PT UNDERWENT PROCEDURE FOR "DISRUPTED" RIGHT CAROTID ARTERY VASCU-GUARD PATCH WITH RIGHT NECK HEMATOMA. PROCEDURE INVOLVED URGENT RIGHT NECK EXPLORATAION WITH REPAIR OF CAROTID ARTERY, REMOVAL OF VASCU-GUARD PATCH AND PLACEMENT OF HEMASHIELD PATCH. SURGEON DESCRIBED PT POSTOPERATIVE STATUS AS "SATISFACTORY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCU-GUARD PERIPHERAL VASCULAR PATCH DXZ BIO-VASCULAR, INC. VG-0106N 533763

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention