ION
Report
- Report Number
- 2955842-2024-18048
- Event Type
- Death
- Date Received
- August 8, 2024
- Date of Event
- July 1, 2024
- Report Date
- April 11, 2025
- 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
A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE SHOWED NO RELATED SYSTEM ERRORS OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE ION SYSTEM FOUND NO NON-CONFORMANCE'S IDENTIFIED TO BE RELATED TO THIS EVENT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT A PATIENT WITH MULTIPLE SCLEROSIS UNDERWENT AN ION ENDOLUMINAL BIOPSY OF A LUNG NODULE WHICH WAS COMPLETED WITHOUT ISSUE AND CONFIRMED A CANCER. THE PATIENT WAS EXTUBATED WITHOUT ISSUE. THE ANESTHESIA TEAM OBTAINED A CT OF THE HEAD WHICH WAS REPORTED AS NORMAL FOLLOWED BY AN MRI WHICH REVEALED EVIDENCE OF STROKE FOR CONTINUED ALTERED SENSORIUM. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR HYPERBARIC OXYGEN THERAPY BASED ON SUSPICION FOR AIR EMBOLISM. THE PATIENT DIED JUST OVER A WEEK LATER. BASED ON THE AVAILABLE DATA, THE REPORTED EVENT WAS PROCEDURE RELATED. THERE WAS NO REPORTED MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES AND THERE IS NO COMPELLING EVIDENCE THAT THE EVENT WAS DEVICE RELATED. 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 (B)(4) 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 ((B)(4)) WITH 71 CASES ((B)(4)) 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. 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. SECTION A2: PATIENT AGE REPORTED AS 50-55 YEARS OLD.
USER FACILITY MEDWATCH RECEIVED VIA FDA THAT STATES: "A 64 Y/O MALE WITH AIR EMBOLISM IN BRAIN POST ROBOTIC NAVIGATION LUNG BIOPSY. ADMITTED TO NEURO ICU AND THEN TRANSFERRED TO HIGHER LEVEL OF CARE, HYPERBARIC TREATMENT. PATIENT EXPIRED." THE USER FACILITY REPORT SOURCE (RISK MANAGER) WAS CONTACT FOR ADDITIONAL INFORMATION; HOWEVER, SHE ADVISED THAT THE REPORTED INCIDENT IS CURRENTLY UNDER COUNSEL, AND PER SUPERVISORY LEADERSHIP, NO FURTHER DETAILS OR INFORMATION COULD BE PROVIDED.
SECTION B5 ADDITIONAL INFORMATION: CONTENT OF A CASE REPORT ABSTRACT POSTER BOARD TO BE DISPLAYED AT A CONFERENCE WAS PROVIDED WITH ATTENDANCE MATERIALS FOR REVIEW. THE MANUFACTURER OF THE "ROBOTIC FLEXIBLE BRONCHOSCOPY SYSTEM" IN THE CASE WAS NOT IDENTIFIED IN THE ABSTRACT. A REVIEW OF THE COMPLAINTS DATABASE FOUND THIS PREVIOUSLY REPORTED EVENT THAT APPEARS TO BE A MATCH FOR THE ABSTRACT DATA. THE UNPUBLISHED ABSTRACT DESCRIBES A CASE OF A ¿64-YEAR-OLD MALE WITH PAST MEDICAL HISTORY OF MULTIPLE SCLEROSIS IN REMISSION PRESENTED AS A TRANSFER FROM OUTSIDE HOSPITAL FOR HYPERBARIC OXYGEN THERAPY (HBO) DUE TO POSSIBLE CEREBRAL VENOUS AIR EMBOLISM FOLLOWING A ROBOTIC FLEXIBLE BRONCHOSCOPY FOR AN ELECTIVE RIGHT LOWER LOBE LUNG NODULE BIOPSY. PATIENT WAS CLINICALLY AND NEUROLOGICALLY STABLE PRIOR TO BIOPSY AND BECAME ALTERED POSTOPERATIVELY.¿ THE ABSTRACT NOTED THAT ¿ON COMPUTED TOMOGRAPHY (CT) HEAD AND NECK AT AN OUTSIDE HOSPITAL, AIR EMBOLI WERE NOTED WITHIN THE SUPERIOR SAGITTAL AND CAVERNOUS SINUS. SUBSEQUENT MAGNETIC RESONANCE IMAGING (MRI) SHOWED INNUMERABLE AND EXTENSIVE TINY AREAS OF RESTRICTED DIFFUSION IN BOTH CEREBRAL HEMISPHERES INVOLVING GRAY AND WHITE MATTER IN MULTIPLE VASCULAR TERRITORIES SUGGESTING DIFFUSE AIR EMBOLI. PATIENT WAS THEN TRANSFERRED AND UNDERWENT EXTENDED SESSIONS OF HBO WITHIN 12 HOURS OF ARRIVAL. ON DAY 4, ACUTE DECOMPENSATION LED TO REPEAT BRAIN MRI WHICH REVEALED INCREASED DISTRIBUTION OF DIFFUSION RESTRICTION IN BILATERAL CEREBRAL HEMISPHERES WITH ASSOCIATED LEPTOMENINGEAL ENHANCEMENT. ELECTROENCEPHALOGRAM (EEG) SHOWED FREQUENT RIGHT POSTERIOR QUADRANT SUBCLINICAL SEIZURES. HE WAS HYPOTENSIVE AND UNABLE TO MAINTAIN MAP WITH THREE PRESSORS. PATIENT DIED OF CARDIAC ARREST ON DAY 5.¿ THE ABSTRACT CONCLUDED THAT ¿AIR EMBOLISM, THOUGH RARE, IS A POTENTIALLY FATAL COMPLICATION FOLLOWING BRONCHOSCOPY WITH BIOPSY. IT IS IMPORTANT TO BE AWARE OF THIS COMPLICATION AND MAINTAIN A LOW THRESHOLD TO SUSPECT AN AIR EMBOLISM, ESPECIALLY IF THERE IS A DELAY IN NEUROLOGICAL RECOVERY POST-PROCEDURE. IF AN AIR EMBOLISM IS SUSPECTED, PROMPT TRANSFER TO A HYPERBARIC OXYGEN CENTER FOR EMERGENT HBO IS RECOMMENDED.¿ CITATION: MONICA PANERU, DO, JINHYUCK KIM, MD, DANILO FRIAS, MD, ANISHA NEUPANE, MD, PRASHANK NEUPANE, MD. UNEXPECTED COMPLICATION: FATAL AIR EMBOLISM FOLLOWING ROBOTIC BRONCHOSCOPY WITH BIOPSY. AMERICAN THORACIC SOCIETY ABSTRACT POSTER BOARD 452.
IT WAS REPORTED THAT AFTER AN ION ASSISTED ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT DID NOT IMMEDIATELY WAKE UP, AND ULTIMATELY EXPIRED. THERE WAS NO REPORT OF ANY ISSUES WITH THE ION SYSTEM, INSTRUMENTS, OR ACCESSORIES. THE LUNG BIOPSY PATHOLOGY REPORT CONFIRMED MALIGNANCY. THE PULMONOLOGIST REPORTED THAT THE ION PROCEDURE WAS A QUICK CASE, VERY SMOOTH WITH NO ISSUES. AT THE END OF THE BIOPSY, 2CC OF EPINEPHRINE WAS INSTILLED DOWN THE ION CATHETER AS STANDARD WORKFLOW DUE TO AN UNSPECIFIED BLEEDING EVENT THAT OCCURRED PRIOR TO THE ION PROCEDURE. THE PATIENT EXPERIENCED TRANSIENT ATRIAL FLUTTER THEREAFTER. THE PATIENT WAS EXTUBATED AND UNSPECIFIED SIGNS OF ALTERED SENSORIUM WERE OBSERVED. A HEAD CT WAS REPORTED TO BE NORMAL; HOWEVER, AN MRI WAS CONCERNING FOR A STROKE THAT WAS LATER CONFIRMED TO BE A MICRO AIR EMBOLISM. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR HYPERBARIC OXYGEN TREATMENT. THE PATIENT¿S COURSE WAS COMPLICATED BY SEIZURES AND CEREBRAL EDEMA; THE PATIENT EXPIRED 8 DAYS POST-PROCEDURE.
REFER TO B6, G2 AND H11 FOR ADDITIONAL/FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1561488 | ION | SYSTEM CART | EOQ | INTUITIVE SURGICAL, INC | 380748-65 | N/A | 00886874116234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Death| R | ION ENDOLUMINAL SYSTEM |