BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT, GDS

    MDR report key: 2963642 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00132
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 1, 2008
    Report Date
    June 29, 2008
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K992960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SMALL SEGMENT OF THE GRAFT (ABOUT 5CM LONG) WAS RECEIVED BY ATRIUM TO DETERMINE THE CAUSE OF PERFORATIONS IN THE GRAFT WALL AND TO DETERMINE IF THE GRAFT WALL WAS THIN AT THE AREA IN CONTACT WITH THE REPORTED PSEUDOANEURYSM. THE SAMPLE WAS EXAMINED GROSSLY PRIOR TO BEING EXAMINED MICROSCOPICALLY. ATRIUM RECEIVED THE SAMPLE COVERED WITH TISSUE GROWN ON THE OUTER SURFACE OF THE GRAFT. THE WALL THICKNESS OF THE EXPLANTED GRAFT SAMPLE FELL WITHIN SPECIFICATION. THIS INDICATES THAT THE GRAFT HAD NO WALL DEFECT IN TERMS OF ONE SEGMENT OF THE WALL BEING TOO THIN AS INDICATED. THERE WERE NO GRAFT DEFECTS FOUND THAT COULD BE DETECTED USING EITHER THE DIGITAL IMAGING MICROSCOPE OR GROSS VISUAL EXAMINATION, OTHER THAN TWO PERFORATIONS THAT ARE CONSISTENT WITH DIALYSIS NEEDLE STICKS (SIZE OF HOLES MEASURED TO BE 0.013" [0.33MM]). THE LOT HISTORY OF THE GRAFT WAS REVIEWED AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. LITERATURE REVIEW SUGGESTS THAT PSEUDOANEURYSM OCCURRENCE IS NOT UNUSUAL AND HAS MANY CAUSES THAT ARE OFTEN IATROGENIC OR BIOLOGIC IN ORIGIN.

    Description of Event or Problem · 1

    THE ADVANTA VXT WITH GDS WAS IMPLANTED IN THE LEFT BRACHIAL REGION OF A (B)(6) FEMALE PT WHO WAS TAKING ORAL STEROIDS, FOR USE AS AN A-V SHUNT, APPROX 20CM IN LENGTH, ON (B)(6) 2007. A POTENTIAL GRAFT ANEURYSM WAS NOTICED IN (B)(6) 2008 AND THE PT WAS FOLLOWED WITHOUT TREATMENT. AN ANGIOGRAM WAS PERFORMED IN (B)(6) 2008 DUE TO AN INCREASE IN SIZE OF THE ANEURYSM, NOW APPROX 2CM. SURGICAL REVISION WAS PERFORMED ON (B)(6) AT WHICH TIME TWO PERFORATIONS IN THE GRAFT WALL WERE SEEN. THE OPERATOR COMMENTED THAT THE GRAFT WALL LOOKED THIN IN THE AREA OF THE PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644 ADVANTA VXT, GDS DSY ATRIUM MEDICAL CORP. 22017 AG05211

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention ORAL STEROIDS