BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 1662207 · Received April 16, 2010

    Report

    Report Number
    2183620-2010-00023
    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 (B) (6) 2002 - (B) (6) 2008. JOURNAL ARTICLE IS ATTACHED: 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 ATTACHED JOURNAL ARTICLE IS A RETROSPECTIVE REVIEW OF 1000 CONSECUTIVE BREAST RECONSTRUCTION VENOUS ANASTOMOSES CASES WHICH WERE PERFORMED USING THE MICROVASCULAR ANASTOMOTIC COUPLER BETWEEN (B) (6) 2002 AND (B) (6) 2008. OVERALL, THERE WERE 6 INSTANCES OF VENOUS THROMBOSIS (0.6%). THE FOURTH VENOUS THROMBOSIS OCCURRED ON POST-OP DAY 4. A SEGMENT OF THE VEIN GRAFT WAS USED TO BRIDGE THE GAP (COUPLED ON BOTH ENDS) AND UROKINASE WAS INFUSED THROUGH THE FLAP. THERE WAS COMPLETE SURVIVAL OF THE FLAP. SAME PROBLEM AND JOURNAL ARTICLE SOURCE AS THE FOLLOWING MFR REPORT NUMBERS, BUT SEPARATE PTS AND EVENTS: 2183620-2010-00020, 2183620-2010-00021, 2183620-2010-00022, 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 GEM2754 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R