BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX THIN

    MDR report key: 10388640 · Received August 10, 2020

    Report

    Report Number
    3005920706-2020-00009
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    December 14, 2017
    Report Date
    July 15, 2020
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K182259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED ANASTOMOTIC LEAK AFTER INITIAL PLACEMENT OF THE ACELL DEVICE . THE ACELL DEVICE WAS NOT EXPLANTED. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE ACELL DEVICE, LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, THE INVESTIGATION IS ONGOING AND MORE INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON 7/15/2020 ACELL, INC. RECEIVED AN ADVERSE EVENT REPORT THROUGH AN ACELL GRANT-SPONSORED STUDY. ON (B)(6) 2017 THE STUDY SUBJECT UNDERWENT A TOTAL GASTRECTOMY WITH ABDOMINAL REGIONAL LYMPHADENECTOMY AND ROUX-EN-Y RECONSTRUCTION WHEREIN THE ANASTOMOSIS WAS WRAPPED WITH AN ACELL GENTRIX DEVICE. ON (B)(6) 2017 THE STUDY SUBJECT DEVELOPED AN ANASTOMOTIC LEAK. AN IR DRAINAGE FOLLOWED BY UNEVENTFUL ENDOSCOPIC STENT PLACEMENT WAS CONDUCTED AND THE ANASTOMOTIC LEAK WAS REPORTED AS RESOLVED ON (B)(6) 2017. THERE ARE NO KNOWN SUBSEQUENT PROCEDURAL INTERVENTIONS OR FOLLOW-UP COMPLICATIONS. THE ACELL DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851372 GENTRIX SURGICAL MATRIX THIN GENTRIX SURGICAL MATRIX THIN FTM ACELL, INC. PSM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention