BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 17821439 · Received September 26, 2023

    Report

    Report Number
    2955842-2023-18753
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 2, 2023
    Report Date
    September 5, 2023
    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

    A REVIEW OF THE EVENT INFORMATION WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND PROVIDED THE FOLLOWING CONCLUSION: SIGNS OF A MYOCARDIAL INFARCTION WERE NOTED DURING AN ION BRONCHOSCOPY DURING NAVIGATION. THE PROCEDURE WAS ABORTED. NO BIOPSIES WERE PERFORMED. EMERGENT CARDIAC CATHETERIZATION WAS ARRANGED AND PERCUTANEOUS CORONARY INTERVENTION WITH STENTS WAS PERFORMED FOR OBSTRUCTIVE CORONARY ARTERY DISEASE. THE PATIENT WAS DISCHARGED HOME AFTER A 2-DAY HOSPITALIZATION. 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 AND NO CARDIAC EVENTS. A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING 415 CASES REPORTED NO CARDIAC EVENTS. MYOCARDIAL ISCHEMIA IS A CONTRAINDICATION TO BRONCHOSCOPY PER BRITISH THORACIC SOCIETY GUIDELINES. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. GIVEN THE AVAILABLE DATA THE CARDIAC EVENT WHICH OCCURRED DURING NAVIGATION PRIOR TO BIOPSY WAS LIKELY DUE TO THE PROCEDURE AND GENERAL ANESTHESIA AND NOT ASSOCIATED WITH THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. 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. RAND IAD, BLAIKLEY J, BOOTON R, ET AL. BRITISH THORACIC SOCIETY GUIDELINE FOR DIAGNOSTIC FLEXIBLE BRONCHOSCOPY IN ADULTS: ACCREDITED BY NICE. THORAX. 2013. 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.BASED ON THE LIMITED AVAILABLE DATA THE EVENT WAS RELATED TO THE PROCEDURE UNDER GENERAL ANESTHESIA AND NOT THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES.

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ADVERSE PATIENT OUTCOME CANNOT BE DETERMINED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND HAD SYMPTOMS OF MYOCARDIAL INFARCTION. AFTER ANESTHESIA INDUCTION AND WHILE NAVIGATING TOWARDS THE TARGET NODULE, THE PATIENT HAD SYMPTOMS OF MYOCARDIAL INFARCTION. THE PROCEDURE WAS ABORTED, AND THE PATIENT UNDERWENT AN EMERGENT CARDIAC CATHETERIZATION. A BLOCKED CORONARY ARTERY WAS FOUND, AND STENTS WERE PLACED TO ADDRESS THE ISSUE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME AFTER 2 DAYS OF HOSPITALIZATION. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832248 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES