BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 7990858 · Received October 22, 2018

    Report

    Report Number
    3005099803-2018-60866
    Event Type
    Death
    Date Received
    October 22, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 22, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF DEATH AND DATE OF THE EVENT ARE UNKNOWN. THE PROVIDED DATE OF DEATH AND EVENT DATE WERE CHOSEN AS A BEST ESTIMATE BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(6). 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 (B)(6) 2018 THAT A HOT AXIOS STENT WAS SUCCESSFULLY IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PROCEDURE, THE PATIENT'S FLUID COLLECTION WAS NOT SHRINKING. THE PATIENT WAS REFERRED TO A SECOND PHYSICIAN TO POTENTIALLY HAVE A SECOND AXIOS STENT PLACED TO FACILITATE FURTHER DRAINAGE. HOWEVER, BEFORE THE PATIENT WAS SEEN BY THE SECOND PHYSICIAN, THE PATIENT DIED SOMETIME BETWEEN (B)(6) 2018. REPORTEDLY, THE PATIENT WAS VOMITING BLOOD PRIOR TO THEIR DEATH. THE PHYSICIAN SUSPECTED THAT THE BLEEDING CAME FROM THE PSEUDOCYST AND THAT THERE MAY HAVE BEEN AN ANEURYSM WITHIN THE PSEUDOCYST THAT THE AXIOS STENT WAS PLACED WITHIN. THE COMPLAINANT REPORTED THAT THERE WAS NO DEFICIENCY OF THE AXIOS STENT. ATTEMPTS BY BOSTON SCIENTIFIC TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT'S CAUSE OF DEATH AND THE RELATIONSHIP BETWEEN THE AXIOS STENT AND THE PATIENT'S DEATH 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
    830831 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death