BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VXT

    MDR report key: 2963556 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00154
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 8, 2011
    Report Date
    February 14, 2011
    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

    THE RETURNED DEVICE WAS EVALUATED. ALMOST THE ENTIRE SURFACE OF THE EXPLANTED GRAFT SEGMENTS RECEIVED WAS COVERED WITH A THIN FILM. DAMAGE TO THE BEADING AND TO THE OUTER SURFACE WAS OBVIOUS THAT MAY HAVE BEEN CAUSED BY IMPROPER HANDLING. THE THIN FILM COULD ONLY BE DETECTED USING THE DIGITAL IMAGING MICROSCOPE. THE WALL THICKNESS OF THE EXPLANTED GRAFT SAMPLE FALLS WITHIN GRAFT SPECIFICATION. THIS INDICATES THAT THE GRAFT HAD NO WALL DEFECT. IN ADDITION, THE LOT HISTORY OF THE GRAFT WAS REVIEWED AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. IT IS NOT KNOWN WHEN THE DAMAGE TO THE BEADING AND THE GRAFT SURFACE OCCURRED, BUT THE DAMAGE TO THE GRAFT SURFACE MAY HAVE CREATED A CONDITION FOR SEROMA BUILD UP. LITERATURE REVIEW SUGGESTS THAT SEROMA FORMATION IS NOT UNUSUAL AND HAS MANY CAUSES THAT ARE OFTEN IATROGENIC OR BIOLOGIC IN ORIGIN. NO DEFINITE CAUSES CAN BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2010 THE GRAFT WAS TUNNELED IN THE ANTERIOR CHEST OF A (B)(6) MALE PATIENT AND SUTURED IN END TO SIDE FASHION TO THE LEFT AND RIGHT AXILLARY ARTERIES. HEPARIN WAS ADMINISTERED AND 5-0 PROLINE SUTURE WAS USED. THE PATIENT RECEIVED PROTAMINE POSTOPERATIVELY. ON (B)(6) 2011 A RE-OPERATION WAS PERFORMED DUE TO A SEROMA FORMATION AROUND THE GRAFT. A 100ML OF LIGHT YELLOW TRANSUDATE FLUID WAS COLLECTED. THE ADVANTA VXT GRAFT WAS CUT AND REMOVED AND THE TISSUE ADHESION SURROUNDING THE GRAFT WAS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597 ADVANTA VXT DSY ATRIUM MEDICAL CORP. 22213 A122507

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PROLENE| PROTAMINE| SUTURES| HEPARIN