BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM FLOW COUPLER DEVICE AND SYSTEM

    MDR report key: 4309238 · Received December 1, 2014

    Report

    Report Number
    2183620-2014-00019
    Event Type
    Injury
    Date Received
    December 1, 2014
    Report Date
    October 27, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K093310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT AVAILABLE. THERE WERE ZERO DEVICE COUPLING PROBLEMS REPORTED AND THE FLOW-COUPLER WAS 100% SENSITIVE IN DETECTING FLAP COMPROMISE IN BOTH THE INTRA- AND POSTOPERATIVE SETTINGS. FLOW-COUPLER RELATED FLAP TAKE BACK AND FLOW-COUPLER RELATED FLAP FAILURE WERE PREVIOUSLY REPORTED IN MFR REPORT # 2183620-2014-00003 AND 2183620-2014-00004. ALL MEDWATCH REPORTS FOR THIS ARTICLE INCLUDE: 2183620-2014-00003, 2183620-2014-00004,2183620-2014-00019, 2183620-2014-00020, 2183620-2014-00021, 2183620-2014-00022. JOURNAL ARTICLE IS ATTACHED: KEMPTON, S. J., POORE, S. O., CHEN, J. T., & AFIFI, A. ANASTOMOTIC VENOUS FLOW COUPLER: ANALYSIS OF 119 CONSECUTIVE ABDOMINAL-BASED FREE FLAPS FOR BREAST RECONSTRUCTION. MICROSURGERY, ADVANCE ONLINE PUBLICATION. DOI 10.1002/MICR.

    Description of Event or Problem · 1

    "FREE FLAP MONITORING USING AN IMPLANTABLE ANASTOMOTIC VENOUS FLOW COUPLER: ANALYSIS OF 119 CONSECUTIVE ABDOMINAL-BASED FREE FLAPS FOR BREAST RECONSTRUCTION" MICROSURGERY 2014. RETROSPECTIVE DATA WAS COLLECTED ON PATIENTS UNDERGOING FREE FLAP BREAST RECONSTRUCTION FROM MAY 2012 TO MARCH 2014. THE VENOUS ANASTOMOTIC FLOW COUPLER WAS USED IN THE FIRST 85 FLAPS AND A NON-FLOW COUPLER WITH CLINICAL AND EXTERNAL DOPPLER MONITORING ALONE IN THE SUBSEQUENT 34 FLAPS. THE AUTHORS REPORT INCIDENCES OF VESSEL THROMBOSIS, FLAP TAKE BACK, FLAP FAILURE, DEVICE FAILURE, ADN WIRE KINKING VESSEL. NO ADDITIONAL INFORMATION IS AVAILABLE. IT CANNOT BE CONCLUDED WHETHER THE FLOW-COUPLER OR COUPLER WAS A CONTRIBUTING FACTOR IN THESE EVENTS. THIS REPORT IS FOR THE FIFTEEN (15) INCIDENCES OF FLOW-COUPLER RELATED VESSEL THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774166 GEM FLOW COUPLER DEVICE AND SYSTEM ANASTOMOTIC COUPLER AND FLOW METER MVR SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other