BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 20274883 · Received September 20, 2024

    Report

    Report Number
    2955842-2024-19804
    Event Type
    Death
    Date Received
    September 20, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 27, 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
    NC, 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 REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY; THE PROCEDURE WAS COMPLETED AND ABOUT AN HOUR AFTER THE PROCEDURE THE PATIENT WAS REPORTED TO HAVE SUFFERED A ¿MINI STROKE¿ ON WORK UP OF AN ALTERED OBTUNDED SENSORIUM. IMAGING WAS NEGATIVE. THE PATIENT WAS REPORTED TO HAVE SUFFERED SEVERAL STROKES RECENTLY INCLUDING TO THE LEFT BASAL GANGLIA AND RIGHT MEDIAL OCCIPITAL LOBE. THE PATIENT WAS ULTIMATELY TRANSITIONED TO HOSPICE AND SUBSEQUENTLY DIED. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE EVENT WAS 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 5 (0.02%) TRANSIENT ISCHEMIC ATTACKS AND 4 (0.02%) TOTAL DEATHS BUT NO STROKES. ANOTHER MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO STROKES AND NO DEATHS ASSOCIATED WITH 581 CASES. A RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 BRONCHOSCOPIES REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO STROKES. ANOTHER PROSPECTIVE SERIES OF 415 ION PROCEDURES REPORTED 1 CVA (0.2%). THE RISK OF STROKE ASSOCIATED WITH GENERAL ANESTHESIA HAS BEEN REPORTED TO VARY FROM 0.1-1.9% IN NON-CARDIAC, NON-NEUROLOGIC, AND NON-MAJOR SURGERY AND AS HIGH AS 10% IN THE SETTING OF BRAIN OR HIGH-RISK CARDIOVASCULAR SURGERY. --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. --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. --BATEMAN BT, SCHUMACHER HC, WANG S, SHAEFI S, BERMAN MF. PERIOPERATIVE ACUTE ISCHEMIC STROKE IN NONCARDIAC AND NONVASCULAR SURGERY: INCIDENCE, RISK FACTORS, AND OUTCOMES. ANESTHESIOLOGY. 2009. --SELIM M. PERIOPERATIVE STROKE. NEW ENGLAND JOURNAL OF MEDICINE. 2007.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY ONE HOUR AFTER THE COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT SUFFERED A STROKE AND SUBSEQUENTLY EXPIRED. THE ENDOLUMINAL SALES ASSOCIATE WAS INFORMED BY THE PULMONOLOGIST THAT THE PATIENT HAD A STROKE AND THAT THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS OF THE SYSTEM OR ANY INSTRUMENTS IN USE DURING THE PROCEDURE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PULMONOLOGIST WERE NOT SUCCESSFUL. A USER FACILITY MEDWATCH (MW) REPORT WAS RECEIVED THAT STATES, ¿A [PATIENT] POST ION ROBOTIC BRONCHOSCOPY. NO REPORTED COMPLICATIONS DURING PROCEDURE. POST PROCEDURE PATIENT WAS UNAROUSABLE, AND A CODE STROKE INITIATED. IMAGING NEGATIVE. PATIENT WAS TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT) FOR ADDITIONAL MANAGEMENT AND TREATMENT. ULTIMATELY TRANSITIONED TO HOSPICE. MULTIPLE RECENT SMALL INFARCTS INCLUDING THE LEFT BASAL GANGLIA AND RIGHT MEDIAL OCCIPITAL LOBE.¿ THE MW ALSO REPORTED THAT THE PATIENT EXPIRED THE SAME DAY OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553720 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-65 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death| R ION ENDOLUMINAL SYSTEM