BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAMIC Y STENT

    MDR report key: 4792591 · Received May 22, 2015

    Report

    Report Number
    3005099803-2015-01445
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 9, 2015
    Manufacturer
    WILLY RUESCH GMBH
    Product Code
    NYT
    PMA / PMN Number
    K953593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DYNAMIC Y STENT WAS USED IN THE TRACHEA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A MALIGNANT STRICTURE CAUSED BY METASTATIC LUNG CANCER. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND HAD NOT BEEN DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN TRIMMED THE DYNAMIC Y STENT TO THE DESIRED LENGTH. THE PHYSICIAN GRASPED THE STENT WITH FREITAG FORCEPS AND ATTEMPTED TO PASS THE STENT THROUGH THE VOCAL CORDS. HOWEVER, UNDER DIRECT VISUALIZATION WITH THE GLIDE SCOPE, THE PHYSICIAN NOTED THAT THE BACK SIDE OF THE STENT HAD TORN. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DYNAMIC Y STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334405 DYNAMIC Y STENT PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC NYT WILLY RUESCH GMBH M00570690 0000013501

    Patients

    Seq Age Sex Outcome Treatment
    1