BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX

    MDR report key: 8774259 · Received July 9, 2019

    Report

    Report Number
    3005920706-2019-00014
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    August 22, 2016
    Report Date
    June 10, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190004416
    PMA / PMN Number
    K162554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE STUDY SUBJECT PARTICIPANT REPORTED SERIOUS ADVERSE EVENT (SAE) WHICH INVOLVED STENT MIGRATION WITH THE DEVELOPMENT OF DYSPHAGIA AND STRICTURE. THE STUDY SUBJECT DEVELOPED THESE SYMPTOMS TWO (2) WEEKS POST IMPLANTATION OF AN ACELL DEVICE HELD IN PLACE BY THE BOSTON SCIENTIFIC WALLFLEX¿ FULLY COVERED ESOPHAGEAL STENT. THE ACELL DEVICE WAS NOT EXPLANTED AND WAS ABSORBED BY THE ONSET OF THE SAE. THE ACELL DEVICE MET SURGEON'S EXPECTATIONS; THE OVERALL OUTCOME WAS THE RESOLUTION OF THE SUBJECT'S BARRETT'S DISEASE; NO BARRETT'S DISEASE HAS BEEN OBSERVED ON SUBJECT PATHOLOGY. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES. THERE WERE NO REPORTS OF DEVICE FAILURE AT THE TIME OF INITIAL SURGERY.

    Description of Event or Problem · 1

    ON 6/10/2019 ACELL, INC. BECAME AWARE OF A CLINICAL TRIAL THAT WAS TERMINATED EARLY DUE TO THE SUBJECT PARTICIPANT EXPERIENCING A SERIOUS ADVERSE EVENT (SAE). THE STUDY TITLE IS "PROSPECTIVE FEASIBILITY STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TRANSORAL ENDOSCOPIC CIRCUMFERENTIAL ESOPHAGEAL RESECTION WITH EXTRACELLULAR MATRIX (ECM) PLACEMENT TO TREAT BARRETT'S ESOPHAGUS WITH HIGH-GRADE DYSPLASIA (HGD)" FOUND ON THE CLINICALTRIALS.GOV WEBSITE UNDER IDENTIFIER (B)(6). THE EXPERIENCED SAE BY THE SUBJECT WAS STENT MIGRATION WITH THE DEVELOPMENT OF DYSPHAGIA AND STRICTURE TWO (2) WEEKS POST IMPLANTATION OF AN ACELL DEVICE HELD IN PLACE BY A BOSTON SCIENTIFIC WALLFLEX¿ FULLY COVERED ESOPHAGEAL STENT. THE STENT WAS REMOVED TWO (2) WEEKS POST OPERATIVE HOWEVER, THE ACELL DEVICE HAD ABSORBED BY THIS TIME. THE ACELL DEVICE MET THE SURGEON'S EXPECTATIONS BY EVIDENCE OF THE SUBJECT'S PATHOLOGICAL OUTCOME; THE RESOLUTION OF THE SUBJECT'S BARRETT'S DISEASE. THERE HAS BEEN NO RECURRENT BARRETT'S DISEASE OBSERVED IN THIS PATIENT'S MUCOSA [PATHOLOGY] TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567116 MATRISTEM SURGICAL MATRIX MATRISTEM SURGICAL MATRIX FTM ACELL, INC. PSMX1015 A000200745 00386190004416

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention