BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM MICROVASCULAR ANASTOMOTIC COUPLER

    MDR report key: 3528339 · Received December 13, 2013

    Report

    Report Number
    2183620-2013-00019
    Event Type
    Injury
    Date Received
    December 13, 2013
    Report Date
    November 14, 2013
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MVR
    PMA / PMN Number
    K861985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE.

    Description of Event or Problem · 1

    VENOUS COUPLER SIZE IN AUTOLOGOUS BREAST RECONSTRUCTION - DOES IT MATTER: WILEY PERIODICALS, INC. MICROSURGERY 33:514-518, 2013. THIS ARTICLE IS A RETROSPECTIVE CHART REVIEW OF PTS UNDERGOING AUTOLOGOUS BREAST RECONSTRUCTION AT NYU MEDICAL CENTER BETWEEN NOVEMBER 2007 AND NOVEMBER 2011. THE 197 PTS UNDERWENT 392 FLAPS, FEATURING 392 GEM COUPLERS, DURING THE STUDY PERIOD. THERE WERE 93 PT COMPLICATIONS NOTED AND ZERO DEVICE MALFUNCTIONS. COMPLICATIONS INCLUDED INCIDENCE OF ARTERIAL INSUFFICIENCY (5), VENOUS INSUFFICIENCY (11), HEMATOMA (13), PARTIAL FLAP LOSS (14), FULL FLAP LOSS (2), FAT NECROSIS (30), AND MASTECTOMY SKIN FLAP NECROSIS (18). THIS REPORT IS FOR THE THIRTY (30) INCIDENCES OF FAT NECROSIS, DEFINED BY PHYSICAL EXAMINATION IDENTIFYING FAT NECROSIS, EXCISION DURING REVISION SURGERY, OR POSTOPERATIVE IMAGING (MRI/CT) DOCUMENTING FAT NECROSIS. ALL REPORTS FOR THIS ARTICLE INCLUDE 2183620-2013-00014 THROUGH 2183620-2013-00020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653115 GEM MICROVASCULAR ANASTOMOTIC COUPLER ANASTOMOTIC COUPLER MVR SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention