BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERGARD AORTIC ARCH WOVEN VASCULAR PROSTHESIS

    MDR report key: 692606 · Received March 24, 2006

    Report

    Report Number
    1640201-2006-00004
    Event Type
    Injury
    Date Received
    March 24, 2006
    Date of Event
    February 14, 2006
    Report Date
    February 20, 2006
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN AORTIC ARCH REPLACEMENT PROCEDURE ON 2/14/2006. DURING SURGERY, BLOOD LEAKING WAS EVIDENCED AT THE SEWN SEAMS BETWEEN THE MAIN TUBE AND THE FIRST AND THIRD BRANCHES OF THE AORTIC ARCH GRAFT. IT WAS REPORTED THAT LEAKAGE WAS EVENTUALLY STOPPED BY COMPRESSION, HAEMOSTATIC PATCHES AND SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD AORTIC ARCH WOVEN VASCULAR PROSTHESIS COLLAGEN COATED WOVEN VASCULAR PROSTHESIS DSY INTERVASCULAR HEWAA2610080810/1 05K13

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention