BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 17424445 · Received July 31, 2023

    Report

    Report Number
    2955842-2023-17407
    Event Type
    Death
    Date Received
    July 31, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 3, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS B6, G3, H2 AND H10. SECTION B5: ADDITIONAL INFORMATION WAS RECEIVED FROM THE PULMONOLOGIST REGARDING THE REPORTED EVENT. A COMPUTED TOMOGRAPHY SCAN DONE IMMEDIATELY AFTER THE ION PROCEDURE WAS WITHOUT EVIDENCE OF STROKE OR AIR EMBOLISM. THE PATIENT WAS TRANSFERRED TO THE ICU WHERE SEIZURES DEVELOPED PROGRESSING TO STATUS EPILEPTICS. AN MRI OF THE BRAIN WAS ALSO WITHOUT EVIDENCE OF A STROKE. THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION INCLUDING AN UNREMARKABLE ECHOCARDIOGRAM. THE LOWEST OXYGEN SATURATION ON REVIEW OF ANESTHESIA RECORDS DURING THE CASE WAS 94%. IMAGING 3 DAYS AFTER THE EVENT SHOWED DIFFUSE BRAIN INJURY. CLINICAL DATA WAS CONSISTENT WITH BRAIN DEATH. THE PATIENT WAS TRANSITIONED TO HOSPICE AND DIED. AFTER REVIEW OF THE DATA, THE TRIGGERING EVENT WAS THOUGHT TO BE OF CARDIAC ETIOLOGY, SPECIFICALLY BRADYCARDIA ATTRIBUTED TO ANESTHESIA SIDE EFFECTS.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO REPORT OR INDICATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT A 72-YEAR-OLD PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY. A 2.9 CM NODULE IN THE RIGHT LOWER LUNG AND 1.4 CM NODULE IN THE LEFT UPPER LOBE WERE BIOPSIED UTILIZING A 21G NEEDLE AND FORCEPS ALONG WITH A BRONCHOALVEOLAR LAVAGE UNDER FLUOROSCOPIC AND RADIAL EBUS GUIDANCE. THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. THERE WAS NO BLEEDING AND NO PNEUMOTHORAX. THE PATIENT DEVELOPED SINUS BRADYCARDIA COMPLICATED BY ASYSTOLE. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED IN LESS THAN 3 MINUTES. THE PATIENT DIED OF ANOXIC ENCEPHALOPATHY. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE. IN A MULTICENTER PROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES THE TOTAL NUMBER OF ANY COMPLICATIONS WAS REPORTED TO BE 227 (1.08%) INCLUDING 5 ARRHYTHMIAS (0.02%) AND 4 TOTAL DEATHS (0.02%). A MULTICENTER STUDY REPORTED 13 (2.2%) COMPLICATIONS WITH NO ARRHYTHMIAS NOR DEATHS ASSOCIATED WITH 581 CASES. A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 REPORTED 1 ASSOCIATED DEATH (0.08%) AND NO ARRHYTHMIAS. ANOTHER SURVEY-BASED STUDY OF 103,978 BRONCHOSCOPIES DESCRIBED 71 CASES (0.068%) OF ANY ASSOCIATED CARDIOVASCULAR EVENTS. ANOTHER MORE RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% INCLUDING A RATE OF 0.02% OF ANY ARRHYTHMIA AND 1 DEATH. GIVEN THE AVAILABLE DATA THE REPORTED ARRHYTHMIA AND DEATH WERE UNLIKELY TO BE RELATED TO THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES AND WAS LIKELY DUE TO THE PROCEDURE UNDER GENERAL ANESTHESIA. **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. **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. **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. SECTION B2: DATE OF DEATH IS ESTIMATED AS THE PROCEDURE DATE. ACTUAL DATE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED SINUS BRADYCARDIA PROGRESSING TO ASYSTOLE. THERE WAS NO PNEUMOTHORAX OR SIGNIFICANT BLEEDING. THE PATIENT'S PULSE RETURNED IN LESS THAN 3 MINUTES, BUT THE PATIENT DIED OF ANOXIC BRAIN INJURY ON AN UNSPECIFIED DATE. TWO NODULES WERE BIOPSIED DURING THE PROCEDURE. THE FIRST LESION WAS 1.4 CM IN SIZE AND WAS LOCATED IN THE LEFT LUNG UPPER LOBE (APICOPOSTERIOR SEGMENT), AND THE SECOND LESION WAS 2.9 CM IN SIZE AND LOCATED IN THE RIGHT LUNG LOWER LOBE (SUPERIOR SEGMENT). INSTRUMENTS USED WERE A 21G FLEXISION NEEDLE WITH COMPATIBLE FORCEPS, AND BRONCHOALVEOLAR LAVAGE. IMAGING MODALITIES INCLUDED C-ARM FLUOROSCOPY AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS). STAGING UTILIZING EBUS WAS NOT DONE. THE DIAGNOSIS OBTAINED FROM PATHOLOGY WAS FOCAL EVIDENCE OF CHANGES/INFLAMMATION (NON-DIAGNOSTIC). THERE IS NO REPORT OF OR INDICATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NO NEW INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645453 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-61 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown ION ENDOLUMINAL SYSTEM