BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 1944855 · Received January 3, 2011

    Report

    Report Number
    3005099803-2010-05409
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED. (B)(4) - STENT FAILED TO EXPAND. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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 COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05409 ADDRESSES THE FIRST ULTRAFLEX STENT THAT WAS USED, WHILE MANUFACTURER REPORT # 3005099803-2010-05410 ADDRESSES THE SECOND ULTRAFLEX STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX COVERED ESOPHAGEAL STENTS WERE USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DEPLOY THE STENT. AFTER REMOVING THE DELIVERY SYSTEM, THE PHYSICIAN CHECKED THE STENT PLACEMENT AND NOTICED THAT THE PROXIMAL FLARE DID NOT FULLY EXPAND; IT HAD BUCKLED INWARDS AND WAS CAUSING AN OBSTRUCTION. THE PHYSICIAN ATTEMPTED TO EXPAND THE STENT BY USING A BALLOON DILATOR, BUT WAS UNSUCCESSFUL. THIS STENT WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PLACE THE SECOND ULTRAFLEX STENT WHEN THE SAME ISSUE OCCURRED (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-05410). AGAIN, THIS STENT WAS REMOVED. AT THIS POINT, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE WITHOUT HAVING IMPLANTED ANY STENTS. 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. THE COMPLAINANT ADDED THAT THERE WAS NO MALFUNCTION WITH THE BALLOON DILATOR USED TO TRY AND EXPAND THE STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00514250 13694128

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention