BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO TRACHEOBRONCHIAL STENT

    MDR report key: 3190180 · Received June 21, 2013

    Report

    Report Number
    1721504-2013-00139
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    JCT
    PMA / PMN Number
    K082284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A LOT NUMBER WAS NOT PROVIDED, A LOT SPECIFIC DEVICE HISTORY RECORD AND COMPLAINT DATABASE SEARCH COULD NOT BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PATIENT PRESENTED WITH AN INTUBATION STRICTURE (FROM WHEN SHE WAS AN INFANT) AND STRIDOR IN (B)(6) 2012. THE PHYSICIAN DILATED THE AREA AND THEN PLACED A 16 X 60 MM STENT. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2013, IT WAS NOTED, THE STENT HAD MIGRATED DISTALLY. THE PHYSICIAN DILATED AND PLACED AN 18 X 40 MM STENT TELESCOPICALLY WITHIN THE PREVIOUS STENT. THE PATIENT DID EXPERIENCE COUGHING WHILE THE STENTS WERE IN PLACE. ON (B)(6) 2013, THE PATIENT PRESENTED WITH A PROXIMAL TRACHEOESOPHAGEAL FISTULA AT THE PROXIMAL FLARE OF THE STENT. BOTH STENTS WERE REMOVED. A MONTGOMERY T-TUBE WAS PLACED ALONG WITH A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. THE PATIENT WAS DISCHARGED. THE USER DID NOT PROVIDE A LOT NUMBER. NO ADDITIONAL HARM OR INJURY WAS REPORTED. DATE OF IMPLANTATION FOR THE 16 X 60 MM STENT IS AN ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283636 AERO TRACHEOBRONCHIAL STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention