BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT

    MDR report key: 2963563 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00147
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    July 20, 2010
    Report Date
    October 21, 2010
    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 4CM LONG, WAS RECEIVED BY ATRIUM TO INVESTIGATE IF THE GRAFT WAS DEFECTIVE. THE EXPLANTED SAMPLE WAS EXAMINED MICROSCOPICALLY AND THE SAMPLE SHOWED HOLES AT TWO DIFFERENT LOCATIONS AT ABOUT 6MM AND 8MM AWAY FROM THE END OF THE RECEIVED GRAFT. IT IS NOT CLEAR IF THE HOLES ARE LOCATED AT THE PROXIMAL OR DISTAL END OF THE GRAFT. AT ONE LOCATION A CLUSTER OF 4 HOLES VARIED IN SIZES. THE CIRCULAR SHAPE OF THE HOLES IN THE GRAFT SURFACE INDICATED THAT THE HOLES WERE PRODUCED BY A SMALL SIZE TIP OBJECT SUCH AS A SUTURE. UPON FURTHER EXAMINATION OF THE EXPLANTED SAMPLE, ADD¿L DAMAGE WAS NOTICED ON THE SURFACE OF THE GRAFT AND DAMAGE TO THE MONOFILAMENT BEADING AS WELL. THIS DAMAGE WAS IN THE SAME VICINITY WHERE THE PINHOLES WERE FOUND ON THE GRAFT. IT IS NOT CLEAR WHEN THE DAMAGE TO THE GRAFT SURFACE OR TO THE BEADING OCCURRED, BUT IT APPEARED THAT THE GRAFT WAS HANDLED OR PINCHED BY HEMOSTATS OR BY ANOTHER CUTTING DEVICE. ATRIUM BELIEVES THIS DAMAGE WAS EVIDENCED BY DEEP CUTS SHOWN ON THE MONOFILAMENT. THE WALL THICKNESS OF THE EXPLANTED GRAFT FELL WITHIN SPECIFICATION AND INDICATES THE GRAFT HAD NO WALL DEFECT. THE LOT HISTORY WAS REVIEWED AND NO DEFECTS OR ANOMALIES WERE FOUND. SINCE IT IS NOT KNOWN WHEN THESE ABRASIONS AND CUTS OCCURRED, IT MAY HAVE LED TO THE GRAFT BEING SEVERELY DAMAGED WHICH COULD HAVE CREATED A CONDITION FOR SEROMA TO BUILD UP.

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED IN THE RIGHT POPLITEAL FOSSA OF (B)(6) MALE PATIENT ON (B)(6) 2009. DURING SURGERY, A SMALL AMOUNT OF BLEEDING OCCURRED FROM A PINHOLE AND IT WAS TREATED WITH HEPARIN AND MANUAL COMPRESSION. THE PATIENT¿S POSTOPERATIVE CONDITION WAS GOOD. THE PATIENT RECEIVED WARFARIN FOR 3 MONTHS POSTOPERATIVELY AND BAYASPIRIN FOR 15 MONTHS POSTOPERATIVELY. ON (B)(6) 2010, A REOPERATION WAS CARRIED ON DUE TO SEROMA FORMATION WHERE THE GRAFT WAS REVISED. DURING THE OPERATION, AN AUTOGENOUS VEIN GRAFTING TOOK PLACE AND THE PATIENT HEMORRHAGED. ON (B)(6) 2010, THE PATIENT UNDERWENT RE-DO OPERATION TO REPAIR THE AUTOGENOUS VEIN SINCE IT HAD A HOLE. THE PATIENT HEMORRHAGED AGAIN AND DECEASED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867 ADVANTA VXT DSY ATRIUM MEDICAL CORP. 22214 AH18905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CV-6 SUTURES| 4.6CC HEPARIN