BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 1328429 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-01791
    Event Type
    Injury
    Date Received
    March 3, 2009
    Date of Event
    October 27, 2005
    Report Date
    November 17, 2005
    Manufacturer
    WILLY RÿSCH GMBH
    Product Code
    ESW
    PMA / PMN Number
    K013266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: SHOULD BE: OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) WAS: NOT CHECKED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2005, THAT ONE WEEK AFTER A POLYFLEX ESOPHAGEAL STENT PROCEDURE, THE PATIENT (WEIGHT UNKNOWN) COMPLAINED OF "PERSISTENT CHEST PAIN". THE PATIENT WAS TAKING "VICODIN FOR A WEEK WITHOUT SIGNIFICANT RELIEF" AND "COULD NOT SLEEP AT NIGHT DUE TO DISCOMFORT". IN 2005, THE PHYSICAN CONFIRMED THAT THE STENT HAD MIGRATED PROXIMALLY. IT WAS LOCATED ABOVE "THE STRICTURE IN THE DISTAL ESOPPHAGUS". THERE WAS "SOME MUCOSA TRAUMA AT PROXIMAL ESOPHAGUS, BUT NO SIGN OF DEEP TEAR OR PERFORATION." THE PATIENT WAS INSTRUCTED TO FOLLOW UP WITH THE PHYSICIAN WITH RECCURRENT DYSPHAGIA.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS A SUPPLEMENT TO MANUFACTURER REPORT # 3005099803-2008-1791.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX ESOPHAGEAL STENT ESW ESW WILLY RÿSCH GMBH M00514300 05061

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other