BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 1662212 · Received April 16, 2010

    Report

    Report Number
    2183620-2010-00020
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    July 1, 2002
    Report Date
    March 19, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT # WAS UNAVAILABLE. IMPLANTED BETWEEN 07/02 - 07/08. JANDALI, S, WU, LC, VEGA, SJ, KOVACH, SJ, SERLETTI, JM. 1000 CONSECUTIVE VENOUS ANASTOMOSES USING THE MICROVASCULAR ANASTOMOTIC COUPLER IN BREAST RECONSTRUCTION. J PLAST RECONSTR SURG. 2010; 125(3) : 792-798.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE IS A RETROSPECTIVE REVIEW OF 1000 CONSECUTIVE BREAST RECONSTRUCTION VENOUS ANASTOMOSES CASES WHICH WERE PERFORMED USING THE MICROVASCULAR ANASTOMOTIC COUPLER BETWEEN JULY 2002 AND JULY 2008. OVERALL, THERE WERE 6 INSTANCES OF VENOUS THROMBOSIS (0.6%). THE FIRST THROMBOSIS OCCURRED INTRAOPERATIVELY, THE ANASTOMOSIS WAS TAKEN OUT, THE THROMBUS IN THE VESSEL WAS FLUSHED OUT WITH HEPARINIZED SALINE AND THE ANASTOMOSIS WAS REDONE WITH A SMALLER COUPLER. THERE WERE NO OTHER THROMBOTIC COMPLICATIONS WITH THE PT AND THE FLAP SURVIVED COMPLETELY. SAME PROBLEM AND JOURNAL ARTICLE SOURCE AS THE FOLLOWING MFR REPORT NUMBERS, BUT SEPARATE PTS AND EVENTS: 2183620-2010-00021, 2183620-2010-00022, 2183620-2010-00023, 2183620-2010-00024, 2183620-2010-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS GEM2753 OR EM2754 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R