BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAMIC Y STENT

    MDR report key: 2854971 · Received December 3, 2012

    Report

    Report Number
    3005099803-2012-05629
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    NYT
    PMA / PMN Number
    K953593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF, 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05629 AND 3005099803-2012-05630 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO DYNAMIC Y STENTS WERE ATTEMPTED TO BE PLACED DURING A PULMONARY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANT OCCLUSION AT THE DISTAL TRACHEA UP TO THE VOICE BOX. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT GET THE STENT (3005099803-2012-05629) DOWN, DUE TO THE OCCLUSION AND TORTUOUS ANATOMY. A SECOND DYNAMIC Y STENT (3005099803-2012-05630) WAS OBTAINED, WHEN TRYING TO PLACE THE SECOND STENT, THE PHYSICIAN RELEASED THE FORCEPS WHICH CAUSED THE STENT TO DROP AND OBSTRUCT THE PATIENT'S AIRWAY. THE PATIENT'S STATS STARTING DROPPING DUE TO THE AIRWAY BEING BLOCKED BY THE STENT, AN EMERGENCY TRACHEOTOMY WAS IMMEDIATELY PERFORMED. THERE WERE NO ATTEMPTS MADE TO REMOVE THE STENT PRIOR TO PERFORMING THE TRACHEOTOMY DUE TO DROP IN THE PATENT'S STATS. THE STENT WAS REMOVED AFTER THE TRACHEOTOMY WAS PERFORMED. THE PATIENT WAS PUT ON A VENTILATOR FOR 4-5 DAYS AND THEN ANOTHER DYNAMIC Y STENT WAS SUCCESSFULLY PLACED THROUGH TRACHEOTOMY SITE. THE PHYSICIAN INDICATED THAT IT WAS VERY DIFFICULT TO PLACE A STENT, DUE TO THE PATIENT ANATOMY (TUMOR LOCATION) AND EDEMA THAT OCCURRED BECAUSE OF MULTIPLE ATTEMPTS TO PLACE A STENT. THE EDEMA WAS NOT TREATED AND LEFT TO RESOLVE ON ITS OWN. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAMIC Y STENT PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC NYT BOSTON SCIENTIFIC - MARLBOROUGH M00570690 0000012081

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR