MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; SYSTEM CART

Model Number	380748-43
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiomyopathy (1764); Myocardial Infarction (1969)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this adverse event.There is no indication that the customer reported complications of bradycardia with hypotension, and st-segment elevations were related to a product issue.The patient was suspected of having an air embolism; however, this was not confirmed via imaging studies.There was no allegation that a malfunction of an ion system, instrument, or accessory occurred during the procedure.System logs are not available for review.A review of the event was conducted by an isi medical officer and the following additional information was provided: a patient of unknown age underwent an ion lung biopsy.At the end of the case after biopsies were obtained the patient developed st segment elevation ecg changes on continuous cardiac monitoring, bradycardia and hypotension.Supportive measures were initiated including intravenous fluids, vasopressors and atropine with which the patient stabilized.The patient was admitted to the icu where cardiology input was obtained with echocardiographic findings concerning for takatsubo¿s cardiomyopathy with elevated troponins.Cardiac catheterization revealed no obstructive coronary artery disease.The patient fully recovered, was extubated and discharged home the following day.Although air embolism was a diagnostic consideration this was not confirmed.A procedure related transient cardiovascular event due to general anesthesia and bronchoscopy is the most likely etiology rather than symptomatic air embolism given its transient nature with full recovery, lack of data confirming air embolism, and relatively rare association with bronchoscopy.Takotsubo cardiomyopathy is a significantly more frequent cause of acute coronary syndrome and has been reported to account for 1-3% of all patients presenting with acute coronary syndrome.Takotsubo cardiomyopathy is a significantly more frequent cause of acute coronary syndrome and has been reported to account for 1-3% of all patients presenting with acute coronary syndrome.Based on the available data the events were procedure related and not device related.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.A 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.A case series of ion robotic assisted bronchoscopies published after the meta-analysis including 415 cases reported no cardiac events.Air embolism is a rare but known complication of bronchoscopic and percutaneous lung biopsies.Symptomatic 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 much 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.Ghadri j-r,j-r, wittstein is, prasad a, sharkey s, dote k, akashi yj et al.International expert consensus document on takotsubo syndrome (part i): clinical characteristics, diagnostic criteria, and pathophysiology.Eur heart j.2018.Templin c, ghadri jr, diekmann j, napp lc, bataiosu dr, jaguszewski m et al.Clinical features and outcomes of takotsubo (stress) cardiomyopathy.N engl j med.2015 wittstein is, prasad a, sharkey s, dote k, akashi yj et al.International expert consensus document on takotsubo syndrome (part i): clinical characteristics, diagnostic criteria, and pathophysiology.Eur heart j.2018.Templin c, ghadri jr, diekmann j, napp lc, bataiosu dr, jaguszewski m et al.Clinical features and outcomes of takotsubo (stress) cardiomyopathy.N engl j med.2015 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.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.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.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during an ion endoluminal lung biopsy procedure, the patient had an acute onset of bradycardia with hypotension, and st-segment elevations suggestive of possible acute myocardial infarction (ami).The episode seemed to occur as the user retracted the ion- instruments and changed to radial endobronchial ultrasound (rebus).The target nodule was located peripherally, and the instruments used were flexision biopsy needle (unknown gauge) and a third-party cytology brush.Multiple passes involved 4 needle aspirations, 1 cytology brush, 5 transbronchial biopsies.The procedure was completed.The patient was treated with vasopressors, atropine, and intravenous fluids.The patient was kept intubated after the procedure and admitted to the medical intensive care unit.A cardiology consult was initiated, and emergent echocardiography was performed which showed possible takotsubo cardiomyopathy with global hypokinesis and the troponins were elevated.The patient underwent cardiac catheterization which showed normal coronary arteries.The patient was extubated the next day and discharged home.The patient had a follow-up echocardiogram which showed a return to normal ejection fraction 2 weeks after the event.A follow-up bronchoscopy was done later to complete the radial endobronchial ultrasound.The patient was suspected of having an air embolism; however, this was not confirmed via imaging studies.The patient was a smoker with no known cardiac history.The physician suspected that the repetitive biopsy of the same approach on a nodule caused more damage/exposure of the blood vessels which was aggravated by higher positive end-expiratory pressure (peep).The physician believed that the retraction of the catheter exposed the biopsied area to high peep and allowed air to enter into the coronary artery vessels.There was no device malfunction associated with the event.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information; however, no further details have been received as of the date of this report.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Section b5 additional information: on 11-apr-2025 a copy of the american thoracic society (ats) abstract was received titled ¿ (poster board # 119) coronary air embolism during robotic bronchoscopy ¿ anderson e, et.Al.No doi link was provided.The abstract will be presented on ats session on 21-may-2025.The author reported that the proposed mechanism of air embolism is that the biopsy tools create a communication between the distal airway and a pulmonary vein adjacent to the target, allowing air to enter the pulmonary veins from the airway and pass through the left atrium to the systemic circulation.The air embolism may selectively navigate to the right coronary artery (rca) due to its anterior origin from the aortic root, resulting in transient inferior st-elevation myocardial infarction (stemi), conduction abnormalities from sinoatrial (sa) node ischemia, and shock.Treatment is supportive, including vasopressors, atropine, intravenous (iv) fluids, and ventilator support.Lower positive end-expiratory pressure (peep) levels after arriving at the target might lower this risk.The abstract concluded that robotic bronchoscopy biopsies carry a small risk of coronary artery air embolism.This rare complication can occur in low-risk individuals and can be life-threatening.Section b6: additional information with follow-up tests.Section a2: additional information about the gender.

• Brand Name: ION
• Common Device Name: SYSTEM CART
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20800416
• Report Number: 2955842-2024-22490
• Device Sequence Number: 12409634
• Product Code: EOQ
• UDI-Device Identifier: 00886874116234
• UDI-Public: (01)00886874116234
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 380748-43
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female