BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 623167 · Received July 26, 2005

    Report

    Report Number
    6000072-2005-00040
    Event Type
    Injury
    Date Received
    July 26, 2005
    Date of Event
    March 22, 2005
    Report Date
    June 28, 2005
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR CLAIMS THAT THE GRAFT WAS IMPLANTED IN 2002, TO REPAIR AN ABDOMINAL AORTIC ANEURYSM (AAA). THE GRAFT OBSSERVED TO HAVE DIALTED "SIGNIFICANTLY" UPON FOLLOW-UP CT SCANS AND/OR MRAS IN 2005. THE LARGEST DIAMETER OF THE GRAFT APROACHES 5.8CM. GRAFT REMAINS IN PT. IN 2005, CO RECEIVED THE FOLLOWING ADDITIONAL/CORRECTED INFORMATION: THE GRAFT WAS IMPLANTED IN 2002. THE INCIDENT DATE IS UNKNOWN AT THIS TIME AND HAS BEEN APPROXIMATED AS 2005 FOR REPORTING PURPOSES ONLY. PT'S PRE-OPERATIVE AND POST-OPERATIVE (ORIGINAL IMPLANT) CONDITION IS UNKNOWN AT THIS TIME. THE CATALOG NUMBER IS 085241 AND THE BATCH NUMBER IS 2823521 AND HAVE BEEN UPDATED/CORRECTED IN THE INTERNAL DATABASE. AS OF 07.2004, NO OTHER ACTIONS HAVE BEEN TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT MAL BOSTON SCIENTIFIC WAYNE 085241 2823521

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other