BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 11947071 · Received June 7, 2021

    Report

    Report Number
    3005099803-2021-02565
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 16, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A07 CAPTURES THE REPORTABLE EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY. BLOCK H10: A HOT AXIOS STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NOSE CONE SEPARATION. THE DELIVERY SYSTEM WAS RECEIVED IN ORIGINAL POSITION. THE TIP OF THE DEVICE SHOWED EVIDENCE OF ELECTROCAUTERY. AN ELECTRICAL INSPECTION WAS PERFORMED TO VERIFY THE CONTINUITY BETWEEN THE RF CONNECTOR AND DISTAL RF ELECTRODE WITH A MULTIMETER; INTERMITTENT RESISTANCE WAS DETECTED DEPENDING ON THE MOVEMENT OF THE OUTER SHEATH. X-RAY ANALYSIS WAS PERFORMED AND IT WAS NOTED THAT THE SIGNAL CABLE WAS KINKED IN DIFFERENT SECTIONS. NO OTHER ISSUES WITH THE STENT AND DELIVERY SYSTEM WERE NOTED. THE REPORTED EVENT OF CAUTERY DELIVERS ENERGY INTERMITTENTLY WAS CONFIRMED AS THERE WAS INTERMITTENT RESISTANCE DURING THE ELECTRICAL INSPECTION. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT AND THE OBSERVED FAILURES WERE LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE. HANDLING AND MANIPULATION OF THE DEVICE DURING PROCEDURE COULD HAVE LED TO THE OBSERVED NOSE CONE SEPARATION. IT MAY BE THAT THE INTERACTION WITH THE SCOPE AND/OR THE TECHNIQUE USED BY THE PHYSICIAN COULD HAVE CAUSED THE PHYSICIAN TO FEEL RESISTANCE WHEN ADVANCING THE DEVICE, WHICH LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE KINKS OBSERVED ON THE SIGNAL CABLE AND THE INTERMITTENT ELECTRICAL FAILURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO THE PROCEDURE. 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, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-02562 AND 3005099803-2021-02565 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 14, 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN A TRANSGASTRIC POSITION DURING AN AXIOS PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE AXIOS CAUTERY (THE SUBJECT OF MFR. REPORT # 3005099803-2021-02562) WAS UNABLE TO CUT THROUGH THE TISSUE AND A SMALL AMOUNT OF BLANCHING WAS NOTED ON THE TISSUE. A SECOND AXIOS STENT (THE SUBJECT OF THIS REPORT) WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-02562 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED IN A TRANSGASTRIC POSITION DURING AN AXIOS PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE AXIOS CAUTERY (THE SUBJECT OF MFR. REPORT # 3005099803-2021-02562) WAS UNABLE TO CUT THROUGH THE TISSUE AND A SMALL AMOUNT OF BLANCHING WAS NOTED ON THE TISSUE. A SECOND AXIOS STENT (THE SUBJECT OF THIS REPORT) WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848128 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550 0027058921

    Patients

    Seq Age Sex Outcome Treatment
    1