BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 20177574 · Received September 9, 2024

    Report

    Report Number
    2955842-2024-19218
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    August 19, 2024
    Report Date
    August 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE ION SYSTEM LOGS FOR THE EVENT FOUND THERE WERE NO OBSERVED EVENTS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS WERE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY, DURING THE PROCEDURE BLEEDING WAS NOTED FROM THE RIGHT MIDDLE LOBE AND THE PROCEDURE WAS ABORTED. IT IS UNCLEAR WHAT INTERVENTIONS WERE TAKEN FOR THE BLEEDING. THE PATIENT SUFFERED A CARDIAC ARREST. RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL AND THE PATIENT DIED. THERE WERE NO REPORTED MALFUNCTIONS OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. GIVEN THE AVAILABLE DATA THE REPORTED EVENT WAS PROCEDURE RELATED AND NOT DEVICE RELATED. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE FOR SIGNIFICANT BLEEDING. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 21 EPISODES OF HEMOPTYSIS OF > 50 ML (0.38%) AND 19 EPISODES < 50ML (0.34%). A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 NAVIGATIONAL BRONCHOSCOPY CASES REPORTED A BLEEDING RATE OF 2.5% OVERALL AND A CTCAE GRADE 2 OR GREATER BLEEDING RATE OF 1.5%. A SINGLE CENTER RETROSPECTIVE REVIEW OF 19,017 BRONCHOSCOPIC BIOPSIES REPORTED A SEVERE BLEEDING RATE OF 0.79% WITH A HIGHER RATE IN MORE CENTRAL LESIONS. ANOTHER LARGE CASE SERIES OF 26,895 BRONCHOSCOPIES WITH BIOPSIES OF ANY TYPE REPORTED ANY BLEEDING IN 41.4% OF CASES BUT A SEVERE BLEEDING RATE OF 1.47%. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. BLEEDING OF ANY SEVERITY WAS REPORTED IN 2.1% OF ALL CASES. THESE DATA REFLECT VARIOUS DEFINITIONS OF ANY BLEEDING IN THE LITERATURE RANGING FROM 0.72-41.4% WITH POSSIBLY MORE CONSISTENT DEFINITIONS OF CLINICALLY SIGNIFICANT BLEEDING RANGING FROM 0.38-1.47%. THE RATE OF DEATHS ASSOCIATED WITH BLEEDING WOULD BE SOME FRACTION OF THE REPORTED BLEEDING RATES AND WILL THUS BE MORE RARE THAN SIGNIFICANT BLEEDING. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 4 TOTAL DEATHS (0.02%). ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 DEATH (0.08%). A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH (0.01%). A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO DEATHS. ---FOLCH EE, PRITCHETT MA, NEAD MA, ET AL. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR PERIPHERAL PULMONARY LESIONS: ONE-YEAR RESULTS OF THE PROSPECTIVE, MULTICENTER NAVIGATE STUDY. JOURNAL OF THORACIC ONCOLOGY. 2019. ---FACCIOLONGO N, PATELLI M, GASPARINI S, ET AL. INCIDENCE OF COMPLICATIONS IN BRONCHOSCOPY. MULTICENTRE PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES. MONALDI ARCHIVES FOR CHEST DISEASE. 2009. ---KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. ---BO L, SHI L, JIN F, LI C. THE HEMORRHAGE RISK OF PATIENTS UNDERGOING BRONCHOSCOPIC EXAMINATIONS OR TREATMENTS. AM J TRANSL RES. 2021. ---BROWNLEE AR, WATSON JJJ, AKHMEROV A, ET AL. ROBOTIC NAVIGATIONAL BRONCHOSCOPY IN A THORACIC SURGICAL PRACTICE: LEVERAGING TECHNOLOGY IN THE MANAGEMENT OF PULMONARY NODULES. JTCVS. 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE THE PATIENT BEGAN BLEEDING, WENT INTO CARDIAC ARREST AND EXPIRED. THE PATIENT HAD A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE INTUITIVE ENDOLUMINAL TERRITORY ASSOCIATE WAS INFORMED THAT AT THE TIME OF THE BIOPSY PROCEDURE, EXCESSIVE BLEEDING ORIGINATED FROM THE RIGHT MIDDLE LOBE AND THE PROCEDURE WAS ABORTED. IT WAS REPORTED THAT EPINEPHRINE MAY HAVE BEEN INSTILLED TO HELP SLOW DOWN THE BLEEDING. THE PATIENT SUBSEQUENTLY WENT INTO CARDIAC ARREST AND CPR WAS PERFORMED WITHOUT SUCCESS. THERE WERE NO REPORTED ERRORS OR MALFUNCTIONS OF THE SYSTEM OR ANY INSTRUMENTS IN USE DURING THE PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252206 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Death DA VINCI INSTRUMENTS AND ACCESSORIES