BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMX

    MDR report key: 3249958 · Received July 24, 2013

    Report

    Report Number
    3005920706-2013-00012
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED SURGICAL INTERVENTION, WHICH OCCURRED AFTER THE INITIAL PLACEMENT OF MATRISTEM SURGICAL MATRIX PSMX DEVICE. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFO IS AVAILABLE. ACELL WILL COMMUNICATE WITH RESPECTIVE SURGEON'S OFFICE TO OBTAIN FURTHER INFO ON PT OUTCOME AND UPDATE MDR ACCORDINGLY.

    Description of Event or Problem · 1

    ACELL'S MATRISTEM SURGICAL MATRIX PSMX DEVICE WAS IMPLANTED ON (B)(6) 2013 IN PT DURING LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR AND NISSEN FUNDOPLICATION. ON (B)(6) 2013, THE PT UNDERWENT A SECONDARY LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR PROCEDURE BY ANOTHER SURGEON FOR REASON UNKNOWN TO ACELL. DURING THIS SECOND LAPAROSCOPIC PROCEDURE, IT WAS NOTED THAT THE HERNIA/DEFECT WAS WELL HEALED, AND THE MAJORITY OF THE GRAFT WAS NO LONGER PRESENT OR EVIDENT. IT WAS ALSO NOTED THAT A SMALL PERCENTAGE OF THE GRAFT WAS CONTINUING TO REMODEL AND COULD BE VISUALIZED. UPON EXAMINATION, IT APPEARED THE STOMACH HAD ADVANCED UP TOWARDS THE DIAPHRAGM WITH ADHESIONS FORMED BETWEEN THE STOMACH AND DIAPHRAGM. THIS WAS CONFIRMED WHEN THE STOMACH COULD NOT BE REDUCED WITH GENTLE TENSION BACK DOWN INTO THE ABDOMEN. THE SURGEON ELECTED THE OPEN ABDOMEN FOR BETTER OBSERVATION AND ANATOMIC MANIPULATION. IN AN ATTEMPT TO SEPARATE THE STOMACH AND DIAPHRAGM, A PERFORATION WAS CREATED IN THE ESOPHAGUS. THE SUBSEQUENT REPAIR WAS PERFORMED THROUGH THE CHEST CAVITY. PATHOLOGICAL RESULTS ON THE TISSUE SPECIMEN REMOVED FROM THE ADHESIONS WERE FOUND TO BE INCONCLUSIVE ("TISSUE UNRECOGNIZABLE") WITH A RE-EVALUATION REQUESTED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345338 MATRISTEM SURGICAL MATRIX PSMX FTM, SURGICAL MESH FTM ACELL INC. SM2801-61

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention