BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 19736431 · Received July 12, 2024

    Report

    Report Number
    2955842-2024-17028
    Event Type
    Death
    Date Received
    July 12, 2024
    Date of Event
    June 24, 2024
    Report Date
    June 24, 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

    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 REPORTED ADVERSE EVENT WAS LIKELY PROCEDURE RELATED. THERE IS NO COMPELLING EVIDENCE THAT THE ADVERSE EVENT WAS ASSOCIATED WITH THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE AND RARELY ASSOCIATED FATAL COMPLICATIONS. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. IN ANOTHER 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%). AIR EMBOLISM IS A RARE BUT KNOWN COMPLICATION OF BRONCHOSCOPIC AND PERCUTANEOUS LUNG BIOPSIES. AIR EMBOLISM HAS BEEN REPORTED TO OCCUR IN 0.06 TO 0.45% OF CASES WITH CT GUIDED LUNG BIOPSIES AND IS ESTIMATED TO OCCUR LESS FREQUENTLY WITH BRONCHOSCOPY. THERE ARE ONLY A HANDFUL OF CASE REPORTS DESCRIBING AIR EMBOLISM ASSOCIATED WITH FLEXIBLE BRONCHOSCOPY. IN A SURVEY OF 103,978 BRONCHOSCOPIES ONLY 1 ARTERIAL AIR EMBOLISM WAS REPORTED (0.00096%) WITH 71 CASES (0.068%) OF ASSOCIATED CARDIOVASCULAR EVENTS. HOWEVER, IT IS POSSIBLE THIS IS AN UNDERESTIMATE AS A FRACTION OF THE CARDIOVASCULAR EVENTS ASSOCIATED WITH BRONCHOSCOPY MAY BE DUE TO ARTERIAL AIR EMBOLISM. REFERENCE: KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. 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). TOMIYAMA N, YASUHARA Y, NAKAJIMA Y, ET AL. CT-GUIDED NEEDLE BIOPSY OF LUNG LESIONS: A SURVEY OF SEVERE COMPLICATION BASED ON 9783 BIOPSIES IN JAPAN. EUROPEAN JOURNAL OF RADIOLOGY. 2006. ISHII H, HIRAKI T, GOBARA H, ET AL. RISK FACTORS FOR SYSTEMIC AIR EMBOLISM AS A COMPLICATION OF PERCUTANEOUS CT-GUIDED LUNG BIOPSY: MULTICENTER CASE-CONTROL STUDY. CARDIOVASC INTERVENT RADIOL. 2014. -HE YP, LIU YL, GAO XL, WANG LH. CEREBRAL ARTERIAL AIR EMBOLISM AFTER ENDOBRONCHIAL ELECTROCAUTERY: A CASE REPORT AND REVIEW OF THE LITERATURE. BMC PULM MED. 2021. ASANO F, AOE M, OHSAKI Y, ET AL. DEATHS AND COMPLICATIONS ASSOCIATED WITH RESPIRATORY ENDOSCOPY: A SURVEY BY THE JAPAN SOCIETY FOR RESPIRATORY ENDOSCOPY IN 2010: COMPLICATIONS OF RESPIRATORY ENDOSCOPY. RESPIROLOGY. 2012.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IN AN ION REGISTRY STUDY UNDERWENT AN ION ENDOLUMINAL BIOPSY PROCEDURE AND DEVELOPED CARDIAC ABNORMALITIES DURING THE PROCEDURE. THE PATIENT LATER HAD A STROKE AND SUBSEQUENTLY PASSED AWAY. NO ION DEVICE MALFUNCTION OCCURRED DURING THE PROCEDURE. AFTER ONE BIOPSY WAS PERFORMED, DURING A BREATH HOLD, THE PATIENT DEVELOPED THIRD DEGREE AV BLOCK LASTING APPROXIMATELY 2 MINUTES, FOLLOWED BY SINUS TACHYCARDIA WITH QRS WIDENING, ST SEGMENT ELEVATION, AND 8-10 BEATS OF VENTRICULAR TACHYCARDIA BEFORE SPONTANEOUS RECOVERY. THE ION PROCEDURE WAS ABORTED. WHILE IN THE POST ANESTHESIA CARE UNIT, THE PATIENT WAS EXTUBATED; HOWEVER BECAME UNRESPONSIVE AND REQUIRED REINTUBATION FOR RESPIRATORY FAILURE. PHYSICAL EXAMINATION DETERMINED THE PATIENT HAD SUFFERED A SEVERE STROKE. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED PRIOR TO A CT SCAN WHICH FOUND MULTIPLE INTRACRANIAL FOCI OF AIR PRESENT ALONG THE MIDLINE AND LEFT FRONTAL PARENCHYMA. MRI SHOWED NUMEROUS INFARCTS THROUGHOUT THE SUPRATENTORIAL BRAIN AND TO A LESSER EXTENT THE CEREBELLUM CONCERNING FOR EMBOLIC EVENTS. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR HYPERBARIC TREATMENT. DUE TO CONTINUED POOR NEUROLOGICAL EXAM, THE FAMILY ELECTED FOR COMFORT CARE AND THE PATIENT PASSED AWAY THE NEXT DAY. THE CAUSE OF DEATH WAS REPORTED TO BE STROKE SECONDARY TO AIR EMBOLISM. THE SOURCE OF THE AIR EMBOLISM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833639 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death| R DA VINCI INSTRUMENTS AND ACCESSORIES