BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 18804759 · Received February 28, 2024

    Report

    Report Number
    2955842-2024-11184
    Event Type
    Death
    Date Received
    February 28, 2024
    Date of Event
    January 30, 2024
    Report Date
    January 30, 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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE ION SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS OCCURRED DURING THE PROCEDURE THAT WERE RELEVANT TO THE REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THE PATIENT EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER CONCLUDED THAT BASED ON THE AVAILABLE DATA, THE CARDIAC EVENT WAS LIKELY PROCEDURE RELATED IN THE SETTING OF SIGNIFICANT MEDICAL COMORBIDITIES INCLUDING KNOWN CORONARY ARTERY DISEASE, COPD, ACTIVE SMOKING AS WELL AS DYSLIPIDEMIA AND LUNG CANCER AND WAS NOT DEVICE RELATED. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 4 ASSOCIATED DEATHS (0.02%) AND 1 MYOCARDIAL INFARCTION (0.004%). A MORE RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO ASSOCIATED EVENTS OF MYOCARDIAL INFARCTION. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO CARDIAC EVENTS. 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. 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. KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. 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 A PATIENT DECOMPENSATED DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM PERFORMED DURING THE EVENT CONFIRMED THE PATIENT SUFFERED A MASSIVE MYOCARDIAL INFARCTION (MI). THE PATIENT LATER DEVELOPED CARDIOGENIC SHOCK AND SUBSEQUENTLY EXPIRED THE SAME DAY. THE PHYSICIAN REPORTED THAT NAVIGATING TO THE FIRST OF TWO LEFT UPPER LOBE LESIONS WAS SUCCESSFUL WITH NO ISSUES ENCOUNTERED. AFTER 2-3 BIOPSY SAMPLES, THE PHYSICIAN OBSERVED THAT WHEN THE BIOPSY NEEDLE WAS EXTENDED THE SHEATH WOULD MOVE A LITTLE WITH IT. THE BIOPSY NEEDLE WAS EXCHANGED AND THE CASE WAS CONTINUED WITHOUT INCIDENT. APPROXIMATELY 15 MINUTES INTO THE PROCEDURE, THE PATIENT¿S HEART RATE DROPPED AND THE PROCEDURE WAS ABORTED. CARDIOPULMONARY RESUSCITATION AND VASOPRESSORS WERE ADMINISTERED. THE PATIENT DID NOT REPORT ANTECEDENT CHEST PAIN PRIOR TO THE PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE MI EVENT WAS RELATED TO THE RISK FACTORS OF A HISTORY OF CORONARY ARTERY DISEASE, LUNG CANCER, CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND CURRENT ACTIVE SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445772 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male ION ENDOLUMINAL SYSTEM.