BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SUIT NIR COVERED BILIARY METALLIC STENT

    MDR report key: 7147244 · Received December 27, 2017

    Report

    Report Number
    3003084171-2017-00013
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 17, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MEDINOL LTD.
    Product Code
    FGE
    UDI-DI
    04953170270659
    PMA / PMN Number
    K150487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INITIALLY SUBMITTED AS INVOLVING MEDINOL'S 510(K) CLEARED BILIARY PRODUCT, THE X-SUIT NIR BILIARY METALLIC STENT (K150487). ON JANUARY 10, 2018, THE PRODUCT ARRIVED AT MEDINOL FOR INVESTIGATION. THE INVESTIGATION REVEALED THAT THE COMPLAINT PRODUCT IS IN FACT A DIFFERENT BILIARY PRODUCT MANUFACTURED BY MEDINOL, THE X-SUIT NIR COVERED BILIARY METALLIC STENT. THE COMPLAINT XS102 WAS DELETED, AND A DIFFERENT COMPLAINT WAS OPENED IN ITS PLACE. THE X-SUIT NIR COVERED BILIARY METALLIC STENT IS NOT CLEARED BY FDA, AND THEREFORE IS NOT COMMERCIALLY DISTRIBUTED IN THE US. AS A RESULT, MEDINOL WOULD LIKE TO RETRACT THE PREVIOUS MDR, AND INFORM FDA THAT ADDITIONAL REPORTS WILL NOT BE PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE STENT WAS BROKEN IN HALF AFTER IT WAS DEPLOYED AT THE LOWER MIDDLE BILE DUCT AND THE BROKEN STENT IN SIDE OF THE DUODENUM WAS FALLEN IN THE DUODENUM. THE CUSTOMER WAS DEPLOYED A NEW STENT INTO THE STENT WHICH REMAINED INTO THE BILE DUCT. THERE WAS NO INJURY TO THE PATIENT. THE CONDITION OF THE PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926716 X-SUIT NIR COVERED BILIARY METALLIC STENT BILIARY, STENT FGE MEDINOL LTD. 10 X 60 MM 04953170270659

    Patients

    Seq Age Sex Outcome Treatment
    1