BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 224897 · Received May 24, 1999

    Report

    Report Number
    6000072-1999-00034
    Event Type
    Death
    Date Received
    May 24, 1999
    Date of Event
    March 20, 1999
    Report Date
    April 29, 1999
    Manufacturer
    BOSTON SCIENTIFIC/VASCULAR
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL CLAIMS THAT THE GRAFT WAS IMPLANTED ON 3/16/1999, IN A PATIENT IN VERY POOR HEALTH, FOR AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. FROM FOUR DAYS POST-OPERATIVELY, THE PATIENT WAS CONFIRMED TO BE EXPERIENCING RENAL FAILURE AND THEN MULTI-SYSTEM FAILURE. ON 3/22/1999, THE DOCTOR BELIEVED THE PATIENT HAD A MYOCARDIAL INFARCTION. ON 3/25/1999, THE PATIENT UNDERWENT AN EXPLORATORY SECOND SURGERY TO FIND OUT THE CAUSE OF THE PATIENT'S CONTINUOUSLY DEGRADING CONDITION. THE DOCTOR STATED THAT DURING THIS SECOND PROCEDURE, THE GRAFT LOOKED GOOD. THE PATIENT EXPIRED OF MULTI-SYSTEM FAILURE ON 4/14/1999. THE DOCTOR ALSO STATED THAT ALTHOUGH THE EXACT CAUSE OF THE EVENT IS UNKNOWN, NEITHER THE MULTI-SYSTEM FAILURE, NOR THE DEATH APPEARED TO BE GRAFT-RELATED AT THAT TIME. NO AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL BOSTON SCIENTIFIC/VASCULAR 085168 1682842

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death