BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6634159 · Received June 12, 2017

    Report

    Report Number
    3005099803-2017-01806
    Event Type
    Injury
    Date Received
    June 12, 2017
    Report Date
    May 19, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE WAS NOT REPORTED; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (B)(4). LITERATURE SOURCE: ITOI, TAKAO, ET AL. "CLINICAL EVALUATION OF A NOVEL LUMEN-APPOSING METAL STENT FOR ENDOSONOGRAPHY-GUIDED PANCREATIC PSEUDOCYST AND GALLBLADDER DRAINAGE (WITH VIDEOS)." GASTROINTESTINAL ENDOSCOPY 75.4 (2012): 870-876.DOI: HTTP://DX.DOI.ORG/10.1016/J.GIE.2011.10.020 THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING A COLD AXIOS STENT AND DELIVERY SYSTEM THROUGH THE ARTICLE "CLINICAL EVALUATION OF A NOVEL LUMEN-APPOSING METAL STENT FOR ENDOSONOGRAPHY-GUIDED PANCREATIC PSEUDOCYST AND GALLBLADDER DRAINAGE (WITH VIDEOS)" WRITTEN BY TAKAO ITOI, ET AL. AND PUBLISHED IN APRIL 2012). ACCORDING TO THE ARTICLE, IN ONE PATIENT, THE AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO TREAT A 57-MM NECROTIC PANCREATIC PSEUDOCYST DURING A PSEUDOCYST DRAINAGE PROCEDURE. THE CYSTGASTROSTOMY TRACT WAS DILATED WITH A 15-MM BALLOON IMMEDIATELY BEFORE INSERTION OF THE 10-MM AXIOS STENT. THE PATIENT UNDERWENT A NECROSECTOMY AFTER THE STENT WAS PLACED. THE ARTICLE REPORTED THAT THE STENT SPONTANEOUSLY MIGRATED INTO THE STOMACH AND WAS REMOVED FROM THE PATIENT 19 DAYS AFTER PLACEMENT. THE ARTICLE DID NOT PROVIDE ANY FURTHER DETAILS REGARDING THIS EVENT. SHOULD ANY ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415555 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH AXS-10-10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention