BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VS

    MDR report key: 2963541 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00151
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    June 4, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    PMA / PMN Number
    K992441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED AND FOUND THE GRAFT MET ALL SPECIFICATIONS. UNFORTUNATELY, THE EXPLANTED GRAFT SAMPLE WAS CUT INTO PIECES TOO SMALL FOR RECONSTRUCTION; THEREFORE, NO EVALUATION COULD BE CONDUCTED. SEROMA FORMATION IS A KNOWN COMPLICATION OF ALL VASCULAR GRAFTS, INCLUDING BIOLOGICAL, POLYESTER, AND PTFE. IT IS WELL KNOWN THAT THE USE OF WETTING AGENTS AROUND THE GRAFT, SUCH AS ALCOHOL, POVIDINE-IODINE, AND HEPARIN SALINE, CAN PENETRATE THE GRAFT WALL CAUSING INCREASED PERMEABILITY TO SERUM. THE COMPLAINT REPORT STATED: ¿REMOVED THROMBUS ON POSTOPERATIVE DAY 2, AND SALINE WAS USED FOR THE PROCEDURE¿. THE USE OF FORCED SALINE COULD CONTRIBUTE TO SEROMA FORMATION.

    Description of Event or Problem · 1

    THE GRAFT WAS INITIALLY IMPLANTED ON (B)(6) 2011 IN THE UPPER ARM. TWO DAYS POST-OPERATIVE, SALINE WAS USED TO REMOVE A THROMBUS IN THE GRAFT. ON (B)(6) 2011, THE PATIENT ASKED FOR THE GRAFT TO BE REMOVED DUE TO SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587 ADVANTA VS DYF ATRIUM MEDICAL CORP. 21603 AJ210607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention