BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS

    MDR report key: 11648087 · Received April 12, 2021

    Report

    Report Number
    3005099803-2021-01532
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 20, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904595
    PMA / PMN Number
    K153088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B5 AND H6 (DEVICE CODE) HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON APRIL 28, 2021. BLOCK H6: MEDICAL DEVICE PROBLEM CODE A15 CAPTURES THE REPORTABLE EVENT OF HOT AXIOS STENT PARTIALLY DEPLOYED. BLOCK H10: A HOT AXIOS STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE OUTER SHEATH PARTIALLY RETRACTED FROM THE STENT. THE HANDLE WAS RETURNED IN "STEP 1". NO OTHER ISSUES WITH THE STENT AND DELIVERY SYSTEM WERE NOTED. THE REPORTED EVENT OF TIP/NOSE CONE MATERIAL SEPARATION CAN BE CONFIRMED AS THE OUTER SHEATH WAS PARTIALLY RETRACTED FROM THE STENT. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT MAY BE DUE TO FACTORS ENCOUNTERED DURING UNPACKING. IT MAY BE THAT THE TIP/NOSE CONE SEPARATED WHEN THE SHEATH WAS PULLED OUT OF THE CARRIER TUBE. HOWEVER, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THE EVENT. THE INVESTIGATION FINDINGS DID NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT. THEREFORE, CAUSE NOT ESTABLISHED WAS SELECTED AS THE MOST PROBABLE CAUSE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS OPENED ON (B)(6) 2021. DURING UNPACKING, THE STENT WAS PARTIALLY DEPLOYED. THERE WAS NO PATIENT INVOLVEMENT. ***ADDITIONAL INFORMATION RECEIVED ON APRIL 28, 2021. IT WAS REPORTED THAT THE FIRST FLANGE WAS NOT FULLY RELEASED AND THE NOSE CONE WAS SEPARATED EXPOSING PART OF THE FIRST FLANGE OF THE STENT. NOTE: ADDITIONAL INFORMATION WAS RECEIVED THAT THE NOSE CONE WAS SEPARATED EXPOSING PART OF THE FIRST FLANGE OF THE STENT AND THE FIRST FLANGE DID NOT FULLY RELEASE. AS THERE IS NO REPORTABLE ALLEGATION AGAINST THE DEVICE ITSELF, AND THERE WAS NO SERIOUS INJURY, BOSTON SCIENTIFIC NO LONGER CONSIDERS THIS TO BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE (B)(4) CAPTURES THE REPORTABLE EVENT OF HOT AXIOS STENT PARTIALLY DEPLOYED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS OPENED ON (B)(6) 2021. DURING UNPACKING, THE STENT WAS PARTIALLY DEPLOYED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546386 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553650 0024618293 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1