BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALIMAXX-E

    MDR report key: 2191945 · Received June 25, 2008

    Report

    Report Number
    3004039296-2008-00006
    Event Type
    Other
    Date Received
    June 25, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ALVEOLUS INC
    Product Code
    JCT
    PMA / PMN Number
    K062511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS INVESTIGATION IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. ALVEOLUS IS UNABLE TO REVIEW THE MANUFACTURING PROCESSING RECORDS FOR THIS STENT SINCE A LOT NUMBER IS NOT AVAILABLE. A SIX-MONTH ALIMAXX-E PRODUCT FAMILY COMPLAINT TREND ANALYSIS, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED FOR THIS PRODUCT.

    Description of Event or Problem · 1

    TWO ALIMAXX-E ESOPHAGEAL STENTS WERE PLACED INTO A PATIENT TO HEAL A LEAK CAUSED FROM A GASTRIC SLEEVE SURGERY. THE TWO STENTS WERE TELESCOPED TOGETHER WITH THE MOST PROXIMAL STENT INTO THE GE-JUNCTION AND THE SECOND STENT INTO THE PYLORUS. THE STENTS REMAINED IN THE PATIENT FOR APPROXIMATELY THREE WEEKS. THE PHYSICIAN ATTEMPTED REMOVAL OF THE STENTS ENDOSCOPICALLY BUT WAS UNSUCCESSFUL DUE TO TISSUE IN-GROWTH INTO THE STENT BODY. THE PHYSICIAN SUCCESSFULLY REMOVED THE STENTS VIA SURGERY. THE PHYSICIAN STATED THE LEAK WAS HEALED AND THE PATIENT WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIMAXX-E ESOPHAGEAL STENT JCT ALVEOLUS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention