BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6666480 · Received June 26, 2017

    Report

    Report Number
    3005099803-2017-01847
    Event Type
    Death
    Date Received
    June 26, 2017
    Report Date
    June 2, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO CONFIRM THE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 02, 2017, THAT A COLD AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION FOR GALLBLADDER DRAINAGE DURING A PROCEDURE IN (B)(6) 2012. REPORTEDLY, THE PATIENT WAS CONSIDERED A HIGH SURGICAL RISK PATIENT. THE STENT WAS PROPERLY PLACED IN A SATISFACTORY LOCATION, DRAINING INTO THE GASTRIC POSTERIOR ANTRUM. ACCORDING TO THE COMPLAINANT, WITHIN HOURS OF THE AXIOS PLACEMENT PROCEDURE, THE PATIENT DEVELOPED PERITONEAL SIGNS, WHICH RAISED SUSPICION OF A LEAK. THE PHYSICIAN DECIDED TO OPERATE ON THE PATIENT. THE PATIENT UNDERWENT A CHOLECYSTECTOMY AND INTRA-PERITONEAL BLEEDING WAS REPORTED. THE PHYSICIAN REPORTED THAT THE BLEEDING WAS NOT RELATED TO THE AXIOS STENTING PROCEDURE AS NO BLEEDING WAS OBSERVED DURING THE ENDOSCOPIC PROCEDURE; THE BLEEDING WAS CONSIDERED RELATED TO SURGERY. THE PATIENT REMAINED HOSPITALIZED AND DIED APPROXIMATELY 1 MONTH AFTER SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448438 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH AXS-10-10

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| H| R