BEUDAMED
    FDA Adverse Event Death Summary report: N

    NITI-S ESOPHAGEAL STENT

    MDR report key: 4133290 · Received September 1, 2014

    Report

    Report Number
    3003902943-2014-00002
    Event Type
    Death
    Date Received
    September 1, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 14, 2014
    Manufacturer
    TAEWOONG MEDICAL CO., LTD
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FINDINGS IN AN AUTOPSY ADMITTED THE ULCER FORMATION IN THE LOWER STENT END (IT IS UNK WHICH STENT LOWER ENDS WAS PERFORATED), WHICH HAS BEEN PERFORATED THE AORTA. THE PERFORATED AREA WAS NOT A SITE OF TUMOR; HOWEVER, THE TISSUE OF THE PERFORATED AREA COULD HAVE BEEN VERY FRAGILE DUE TO RADIATION THERAPY PERFORMED IN THE PAST. (NO SPECIFIC INTO AVAILABLE ON THE RADIATION THERAPY) SEVERAL CONGESTION LINES WERE ALSO ADMITTED ON THE ESOPHAGEAL WALL, BUT IT REMAINS UNK WHERE EXACTLY THESE CONGESTION LINES FORMED IN THE IMPLANTED TWO STENTS. WE CHECK DEVICE HISTORY RECORD FOR THE SUSPECT DEVICE. THERE WAS NO SIGNIFICANT TO REPORT. THE SUSPECT DEVICE WAS DISCARDED AT USER FACILITY. SO, WE CANNOT PROCEED FURTHER INVESTIGATION. MEDICAL OPINIONS: NO WORD AS TO WHETHER NITI-S STENT IS ATTRIBUTABLE TO THE PT DEATH OR NOT; HOWEVER, IT SEEMS LIKE STENT SHORTING (NITI-S) OCCURRED GIVEN THAT THE NITI-S STENT ORIGINALLY IMPLANTED JUST 2-3 CM BELOW THE LOWER END (OUT OF) OF THE FIRST STENT WAS FOUND TO BE ONLY 1CM.

    Description of Event or Problem · 1

    (B)(6) 2013: AN ESOPHAGEAL STENT (COOK EVOLUTION ESOPHAGEAL STENT 18MM X 10CM) WAS APPLIED TO MIDDLE AND LOWER ESOPHAGUS DUE TO ESOPHAGEAL CANCER. (B)(6) 2014: AFTER TWO MONTHS FROM THE FIRST STENT IMPLANTATION, TUMOR OVERGROWTH WAS ADMITTED AT THE LOWER END OF THE STENT. NITI-S STENT (EST1808F) WAS IMPLANTED IN 2-3CM BELOW THE LOWER END OF THE FIRST STENT, ANATOMICALLY JUST ABOVE THE EGJ. PROCEDURE WENT SUCCESSFULLY. THE PT CONDITION WAS REPORTED TO BE GOOD; THE PT COULD GO BACK TO WORK AND EAT WITHOUT A PROBLEM. (B)(6) 2014 AT 20:00: THE PT'S CONDITION SHARPLY DETERIORATED, VOMITED BLOOD AND WAS URGENTLY TRANSPORTED TO THE HOSPITAL. AS A RESULT OF CT SCAN, THE PT WAS DIAGNOSED AS HAVING AN AORTOENTERIC FISTULA. BLOOD TRANSFUSION AS PERFORMED TO THE PT. (B)(6) 2014 AT 00:54: THE PT AGAIN VOMITED BLOOD AND DIED FROM AORTIC PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531561 NITI-S ESOPHAGEAL STENT ESOPHAEAL STENT ESW TAEWOONG MEDICAL CO., LTD EST1808F

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death COOK EVOLUTION ESOPHAGEAL STENT 18MM X 10CM