BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIMAXX-ES ESOPHAGEAL SEM STENT

    MDR report key: 2255830 · Received August 22, 2011

    Report

    Report Number
    1721504-2011-00246
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    April 12, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    ESW
    PMA / PMN Number
    K080838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. EVALUATION CONCLUSIONS: A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STENT WAS PLACED ON (B)(6) 2011 FOR A POST OPERATIVE LEAK. THE STENT WAS PLACED INTO THE STOMACH WHERE IT WAS EXPOSED TO GASTRIC MUCOSA BUT DID NOT MIGRATE. THERE WAS A SMALL AMOUNT OF INGROWTH VISIBLE ASSOCIATED WITH THE LOSS OF COVERING. THE STENT WAS REMOVED WITHOUT ANY COMPLICATION. THE PROXIMAL END OF THE STENT WAS UNDAMAGED. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIMAXX-ES ESOPHAGEAL SEM STENT PROSTHESIS, ESOPHAGEAL ESW MERIT MEDICAL SYSTEMS, INC. H199981L

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR