BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA SST

    MDR report key: 2963559 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00152
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 11, 2008
    Report Date
    January 9, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K010516
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE GRAFT WAS RETURNED DRY IN NO FIXATIVE, IN THE ORIGINAL GRAFT TRAY. THE GRAFT WAS YELLOW IN APPEARANCE. THE QC RECORDS FOR THIS LOT OF GRAFT MATERIAL WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. ALL RECORDS, DATA AND OBSERVATIONS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL MECHANICAL PROPERTIES, INCLUDING THE WATER ENTRY PRESSURE, FOR THIS LOT OF GRAFTS WERE WITHIN SPECIFICATIONS. THE LIKELY CAUSE OF WEEPING IN THIS GRAFT WAS THE FORCING OF SALINE THROUGH THE GRAFT WALL, ESPECIALLY WHILE CLAMPED. THE INSTRUCTIONS FOR USE FOR ADVANTA PTFE GRAFTS SPECIFICALLY STATE: ¿DO NOT PRE-WET THE ADVANTA PTFE GRAFT BY EXPOSURE TO ORGANIC SOLVENTS SUCH AS ALCOHOL OR FORCE AQUEOUS SOLUTIONS THROUGH THE GRAFT WALL AS THE HYDROPHOBIC PROPERTIES OF THE GRAFT MAY BE EFFECTED, WHICH MAY RESULT IN EXCESSIVE SERUM LEAKAGE AND/OR SEROMA FORMATION¿.

    Description of Event or Problem · 1

    DURING IMPLEMENTATION OF THE BYPASS THE SURGEON USUALLY FILLS UP THE GRAFT WITH A SALT SOLUTION TO AVOID TORSION AND TO BE ABLE TO CONNECT IT SAFELY WITH BOTH ENDS OF THE VEIN. DURING THIS PROCEDURE HE FOUND THAT THE SALT LIQUID COULD ESCAPE TOO EASILY THROUGH THE GRAFT WALL AND WHEN HE DISCONNECTED THE CLAMPS WHICH KEPT THE VEIN CLOSED, TOO MUCH BLOOD WENT OUT OF THE WALL. HE DECIDED TO IMMEDIATELY REPLACE THE GRAFT WITH ANOTHER ONE FROM THE SAME REFERENCE. HE PUT THE NEW ONE USING THE SAME PROCEDURES, THE PROBLEM DID NOT RE-OCCUR AND HE FINISHED THE INTERVENTION SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509 ADVANTA SST DSY ATRIUM MEDICAL CORP. 25003 AH05809

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention