BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITI-S ESOPHAGEAL COVERED STENT

    MDR report key: 4792695 · Received May 18, 2015

    Report

    Report Number
    3003902943-2015-00023
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 27, 2015
    Manufacturer
    TAEWOONG MEDICAL CO., LTD
    Product Code
    ESW
    PMA / PMN Number
    K123205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST, IT IS CONFIRMED FROM THE DEVICE HISTORY RECORD THAT THE SUBJECT PRODUCT HAD BEEN MANUFACTURED WITH NO SIGNIFICANT ISSUE AND PASSED ALL THE INSPECTIONS. AS RESULTS FROM INVESTIGATING THE RETURNED DEVICE, THE OUTER SHEATH HAS BEEN CUT OFF, AND STENT WAS PARTIALLY DEPLOYED. ATTEMPTING DEPLOY WITHOUT PRESSURE, IT WORKED WELL. THERE WERE KINKED MARKS AT INNER SHEATH. THE OPERATED REGION, ESOPHAGEAL STRUCTURE, IS A PART OF HAVING AN ACTIVE PERISTALSIS. THE PRESSURE OCCURRED FROM VARIOUS CONDITION OF A PATIENT'S LESION CAN CAUSE A RESISTANCE DURING THE DEPLOYMENT. OUTER SHEATH CAN BE STRETCHED AND DISCONNECTED WHEN THE DEPLOYMENT IS ATTEMPTED IN SUCH CONDITION. SINCE IT IS DIFFICULT TO RECONSTRUCT IN THE LAB AND LIMITED INFORMATION AT THAT TIME, IT IS HARD TO FIND OUT EXACT ROOT CAUSE FOR THIS COMPLAINT. ALSO THERE IS NO PATIENT'S INFO. THIS DEPLOYMENT FAILURE SEEMS THAT IT HAPPENED BECAUSE THE DEPLOYMENT WAS ATTEMPTED WITH CONSISTENT FORCE WHEN THE PART OF STENT LOADED OUTER SHEATH HAD BEEN SNAPPED, THUS EVENTUALLY CUT OFF. ADDITIONALLY, AS RESULTS FROM INVESTIGATING THE RETURNED DEVICE THAT STENT WAS DEPLOYED WITHOUT ANY EXTERNAL PRESSURE WHICH MAY HAD AFFECTED IT INSIDE OF PT DURING THE OPERATION, IT SUPPORTS THE OPINION THAT THE OUTER SHEATH WAS DAMAGED BY BEING SNAPPED AND THUS CAUSED THE INOPERABLE CONDITION. THIS CUSTOMER COMPLAINT OCCURRED IN THE US. EVEN THOUGH THERE WAS NO DAMAGE TO THE PT DUE TO THIS INCIDENT, IT WAS DECIDED BY THE FIRM THAT WE PROCEED MDR REPORTING AS AN EVENT OF PRODUCT MALFUNCTION. THE FIRM WILL ALSO START MONITORING SIMILAR CASES IN CASE OF OCCURRENCE IN THE FUTURE.

    Description of Event or Problem · 1

    WHEN THE ATTEMPT WAS MADE TO DEPLOY THE STENT, THERE WAS A SNAP AND THE BLUE SHEATH CAME UNATTACHED FROM THE DEPLOYING END OF THE STENT MAKING IT UNABLE TO DEPLOY. NO PT INJURY AND THE FACILITY USED ANOTHER TTS STENT AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321178 NITI-S ESOPHAGEAL COVERED STENT ESOPHAGEAL STENT ESW TAEWOONG MEDICAL CO., LTD EST1815F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK