BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? DUODENAL

    MDR report key: 3201252 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06361
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. : THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. PERFORATION AND PAIN ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE, AND ARE LISTED IN THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED BETWEEN THE PYLORUS AND THE DESCENDING LIMB OF THE DUODENUM ON (B)(6) 2013, DURING A DUODENAL STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TREATMENT OF A STRICTURE. THE PATIENT HAD NOT BEEN UNDERGOING CANCER TREATMENTS BUT IS ALSO UNDER OBSERVATION FOR LIVER DISEASE. DURING THE PROCEDURE, THERE WERE NO VISIBLE ISSUES NOTED TO THE STENT AND THE STENT PLACEMENT PROCEDURE WAS SUCCESSFUL. HOWEVER; THE PATIENT COMPLAINED OF STOMACH PAIN ON (B)(6) 2013. ON (B)(6) 2013, CT AND X-RAY EXAMS WERE PERFORMED AND FREE AIR WAS CONFIRMED NEAR THE STENT. THE PHYSICIAN ADMINISTERED ANTIBIOTICS TO THE PATIENT TO TREAT THE PERFORATION AS A CONSERVATIVE TREATMENT. THE STENT REMAINS IMPLANTED. IN THE PHYSICIAN¿S ASSESSMENT, THE STENT CONTRIBUTED TO THE PERFORATION; HOWEVER THERE WAS NO MALFUNCTION WITH THE STENT. THE PATIENT HAS SINCE RECOVERED AND IS ABLE TO TAKE MEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301669 WALLFLEX? DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention