BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 1481580 · Received September 22, 2009

    Report

    Report Number
    3005099803-2009-04449
    Event Type
    Injury
    Date Received
    September 22, 2009
    Date of Event
    August 26, 2009
    Report Date
    August 26, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ESW
    PMA / PMN Number
    K080332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE; THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX ESOPHAGEAL STENT WAS USED DURING A SUCCESSFUL STENT PLACEMENT PROCEDURE IN 2009. THE STENT WAS PLACED WITH NO APPARENT ISSUES. ACCORDING TO THE COMPLAINANT, EIGHT WEEKS POST IMPLANTATION, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT AS HE FELT THE STENT HAD CLINICALLY DONE ITS JOB. HOWEVER, DURING THE REMOVAL ATTEMPT, THE STENT BECAME DISLODGED AND MIGRATED. A C-ARM (X-RAY IMAGE INTENSIFIER) WAS USED TO IDENTIFY THAT THE STENT WAS LOCATED SOMEWHERE IN THE SMALL BOWEL; HOWEVER, IT COULD NOT BE RETRIEVED. THE PROCEDURE WAS DISCONTINUED AT THAT TIME. THE PHYSICIAN HAS DECIDED TO LEAVE THE STENT IN PLACE AND X-RAY ON A BI-WEEKLY BASIS. THE PATIENT WILL BE FOLLOWED CLOSELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC CORPORATION M00514340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other