BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 20122526 · Received September 2, 2024

    Report

    Report Number
    2955842-2024-18981
    Event Type
    Death
    Date Received
    September 2, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 13, 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
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE ION SYSTEM FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THE REPORTED EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT A PATIENT WITH COPD AND EMPHYSEMA UNDERWENT AN ION ENDOLUMINAL BIOPSY AND EBUS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND IMAGING REVEALED NO PNEUMOTHORAX. THE PATIENT WAS EXTUBATED AND TRANSPORTED TO RECOVERY. IN RECOVERY THE PATIENT REPORTED DIFFICULTY BREATHING FOLLOWED BY CARDIOPULMONARY ARREST. EFFORTS AT RESUSCITATION FOR 20 MINUTES WERE UNSUCCESSFUL AND THE PATIENT DIED. BASED ON THE AVAILABLE DATA A CARDIOVASCULAR EVENT INCLUDING PULMONARY EMBOLISM IS THE MOST LIKELY TRIGGERING EVENT. THERE WERE NO MALFUNCTIONS OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. THE EVENT WAS LIKELY PROCEDURE RELATED AND NOT DEVICE RELATED. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE AND RARELY ASSOCIATED WITH FATAL COMPLICATIONS. IN A MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) WITH 4 TOTAL DEATHS (0.02%). A MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO DEATHS ASSOCIATED WITH 581 CASES. A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%). ANOTHER SURVEY-BASED STUDY OF 103,978 BRONCHOSCOPIES DESCRIBED 71 CASES (0.068%) OF ASSOCIATED CARDIOVASCULAR EVENTS. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF (B)(4) WITH 1 DEATH. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO DEATHS. --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;71(1). --OST DE, ERNST A, LEI X, ET AL. DIAGNOSTIC YIELD AND COMPLICATIONS OF BRONCHOSCOPY FOR PERIPHERAL LUNG LESIONS. RESULTS OF THE AQUIRE REGISTRY. AM J RESPIR CRIT CARE MED. 2016;193(1):68-77. --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 FOLLOWING AN UNEVENTFUL ION ASSISTED TRANSBRONCHIAL LUNG BIOPSY PROCEDURE THE PATIENT EXPIRED. THE ION BIOPSY PROCEDURE AND SUBSEQUENT EBUS PROCEDURES WERE COMPLETED WITHOUT ISSUE. A POST-PROCEDURAL SCAN DID NOT IDENTIFY A PNEUMOTHORAX AND THE PATIENT WAS EXTUBATED AND MOVED TO RECOVERY IN STABLE CONDITION. THE PHYSICIAN REPORTED THAT AFTER 16 MINUTES THE PATIENT BEGAN EXPERIENCING DIFFICULTY BREATHING AND WENT INTO RESPIRATORY ARREST, LEADING TO A SUSPECTED BRADYCARDIC EVENT (HEART RATE 40 BPM) AND SUBSEQUENTLY CODED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED FOR APPROXIMATELY 20 MINUTES WITHOUT REVIVAL. THE PHYSICIAN SUSPECTED A MASSIVE PULMONARY EMBOLISM BECAUSE OF THE SEQUENCE OF RESPIRATORY DISTRESS/ARREST LEADING TO BRADYCARDIA AND THEN CARDIAC ARREST. PER THE PHYSICIAN, THE ION SYSTEM DID NOT CAUSE OR CONTRIBUTE THE DEATH. THE PATIENT HAD A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104762 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death ION ENDOLUMINAL SYSTEM