BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERGARD WOVEN VASCULAR PROSTHESIS

    MDR report key: 678338 · Received February 17, 2006

    Report

    Report Number
    1640201-2006-00002
    Event Type
    Death
    Date Received
    February 17, 2006
    Date of Event
    November 26, 2005
    Report Date
    January 17, 2006
    Manufacturer
    INTERVASCULAR
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN ASCENDING THORACIC AORTA REPLACEMENT PROCEDURE IN 2005 FOR REPAIR OF AN ACUTE AORTIC DISSECTION. BLEEDING WAS OBSERVED ON THE GRAFT SURFACE AND AT SUTURE AND SUTURE HOLES. IT WAS REPORTED THAT THE PT DIED AFTER SURGERY. THE EXACT CAUSE OF THE DEATH IS UNCLEAR. NOTE THAT IT WAS ALSO REPORTED THAT TWO GRAFTS WERE USED FOR THIS PROCEDURE. HOWEVER, IT IS UNCLEAR WHETHER THESE TWO GRAFTS WERE SEWED TOGETHER AND WHETHER BLEEDING WAS ACTUALLY OBSERVED AT THE GRAFT-TO-GRAFT ANASTOMOSIS. IT SHOULD BE ALSO NOTED THAT THE SECOND GRAFT (AN INTERGARD KNITTED GRAFT) IS, AS STATED IN THE PRODUCT INSTRUCTIONS FOR USE, CONTRA-INDICATED FOR REPAIR OF THE THORACIC AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGARD WOVEN VASCULAR PROSTHESIS COLLAGEN COATED WOVEN VASCULAR PROSTHESIS DSY INTERVASCULAR IGW00026-30 05A20

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death