ION
Report
- Report Number
- 2955842-2023-17753
- Event Type
- Death
- Date Received
- August 15, 2023
- Date of Event
- June 29, 2023
- Report Date
- July 17, 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
- MS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE ADVERSE PATIENT OUTCOME CANNOT BE DETERMINED. THE PULMONOLOGIST STATED THE BLEEDING WAS CAUSED BY THE BIOPSY PROCEDURE, BUT THERE WAS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. THE EVENT WAS ATTRIBUTED TO LIKELY BE DUE TO THE PATIENT¿S LONGSTANDING VENOUS CONGESTION FROM INTERSTITIAL LUNG DISEASE (ILD) AND BLEEDING FROM THE MALIGNANT TISSUE. 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 A PATIENT WITH SEVERAL WEEKS OF MILD HEMOPTYSIS UNDERWENT AN ION ENDOLUMINAL LEFT LOWER LOBE LUNG BIOPSY. MILD POST BIOPSY BLEEDING WAS CONTROLLED WITH COLD SALINE. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AND THE PATIENT WAS EXTUBATED. IN THE POST-OP AREA BLOODY SPUTUM IN MODERATE AMOUNTS CONTINUED. POST-PROCEDURE COMPLICATIONS BEGAN WITH WORSENING HEMOPTYSIS REQUIRING ENDOTRACHEAL BLOCKERS AND AN EMPIRIC BRONCHIAL ARTERY EMBOLIZATION. WHEN ENDOBRONCHIAL CLOTS WERE REMOVED THE HEMORRHAGE RETURNED, REQUIRING CLOT REMOVAL IN THE OR DUE TO DIFFICULT VENTILATION. PULMONARY ANGIOGRAM CONFIRMED THERE WAS NO BLEEDING FROM THE BRONCHIAL OR PULMONARY ARTERIES. SUBSEQUENTLY, CLOT REMOVAL FROM THE ENDOTRACHEAL TUBE AND DISTAL TRACHEA LED TO REPEAT HEMORRHAGE REQUIRING AN EMERGENT, SUCCESSFUL LOBECTOMY. THE PATIENT THEN CLINICALLY IMPROVED, HOWEVER, WAS NOT ABLE TO BE EXTUBATED. THE HOSPITAL STAY WAS COMPLICATED BY ACUTE KIDNEY INJURY (AKI) REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), AND SEPTIC SHOCK. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. GIVEN THE AVAILABLE DATA, THE BLEEDING AND SEQUELAE, INCLUDING DEATH, IS LARGELY ATTRIBUTED TO A BIOPSY PERFORMED IN THE SETTING OF IDIOPATHIC THROMBOCYTOPENIC PURPURA ASSOCIATED WITH CHRONIC THROMBOCYTOPENIA (NO VALUE AVAILABLE IMMEDIATELY PREBIOPSY), AND CKD WITH ADDITIONAL CO-MORBIDITIES INCLUDING INTERSTITIAL LUNG DISEASE AND PULMONARY HYPERTENSION ASSOCIATED WITH SCL-70 ANTIBODIES CONSISTENT WITH SYSTEMIC SCLEROSIS. THERE IS NO EVIDENCE THE EVENT WAS DEVICE RELATED. BRONCHOSCOPY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW RISK PROFILE. A RETROSPECTIVE STUDY OF 20,986 BRONCHOSCOPIES REPORTED 21 EPISODES OF HEMOPTYSIS OF > 50 ML (0.38%) AND 19 EPISODES < 50 ML (0.34%). A PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF 1,215 NAVIGATIONAL BRONCHOSCOPY CASES REPORTED A BLEEDING RATE OF 2.5% OVERALL AND A CTCAE GRADE 2 OR GREATER BLEEDING RATE OF 1.5%. A SINGLE CENTER RETROSPECTIVE REVIEW OF 19,017 BRONCHOSCOPIC BIOPSIES REPORTED A SEVERE BLEEDING RATE OF 0.79% WITH A HIGHER RATE IN MORE CENTRAL LESIONS. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN 10,381 PATIENTS REPORTED AN OVERALL ADVERSE EVENT RATE OF 5.6% WITH 1 DEATH. BLEEDING OF ANY SEVERITY WAS REPORTED IN 2.1% OF ALL CASES. BTS (BRITISH THORACIC SOCIETY) GUIDELINES FOR FLEXIBLE BRONCHOSCOPY RECOMMENDS TO LIAISE WITH A HEMATOLOGIST REGARDING NEED FOR PLATELET TRANSFUSION FOR THROMBOCYTOPENIA PRIOR TO BRONCHOSCOPIC BIOPSY DUE TO A LACK OF EVIDENCE. BTS GUIDELINES FOR IMAGE GUIDED LUNG BIOPSY STATES THAT A PLATELET COUNT OF <100K/ML IS A RELATIVE CONTRAINDICATION FOR LUNG BIOPSY. A SMALL CASE SERIES OF BRONCHOSCOPIC BIOPSY IN THROMBOCYTOPENIA RECOMMENDED A PLATELET COUNT OF <20K/ML AS AN ABSOLUTE CONTRAINDICATION DUE TO AN INCREASED RISK OF BLEEDING. THE AMERICAN ASSOCIATION OF BLOOD BANKS HAS NO SPECIFIC RECOMMENDATIONS REGARDING BRONCHOSCOPY BUT RECOMMENDS A PLATELET COUNT OF >50K/ML FOR LUMBAR PUNCTURE AS WELL AS FOR MAJOR NON-NEURAXIAL SURGERIES. IN ADDITION TO THROMBOCYTOPENIA, THERE IS ALSO AN INCREASED RISK OF BLEEDING ASSOCIATED WITH CKD. IN A PROSPECTIVE STUDY OF 19,114 PATIENTS, OLDER PATIENTS WITH CKD HAD A 35% INCREASED RISK OF MAJOR HEMORRHAGE. ALTHOUGH PULMONARY HYPERTENSION IS THOUGHT TO BE ASSOCIATED WITH A HIGHER RISK OF COMPLICATIONS INCLUDING BLEEDING THERE IS A PAUCITY OF DATA ON THIS TOPIC AND NO INCREASED RISK WAS REPORTED IN THREE RETROSPECTIVE STUDIES. 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. 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. KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. BO L, SHI L, JIN F, LI C. THE HEMORRHAGE RISK OF PATIENTS UNDERGOING BRONCHOSCOPIC EXAMINATIONS OR TREATMENTS. AM J TRANSL RES. 2021. RAND IAD, BLAIKLEY J, BOOTON R, ET AL. BRITISH THORACIC SOCIETY GUIDELINE FOR DIAGNOSTIC FLEXIBLE BRONCHOSCOPY IN ADULTS: ACCREDITED BY NICE. THORAX. 2013. PAPIN TA, LYNCH JP, WEG JG. TRANSBRONCHIAL BIOPSY IN THE THROMBOCYTOPENIC PATIENT. CHEST. 1985. KAUFMAN RM, DJULBEGOVIC B, GERNSHEIMER T, ET AL. PLATELET TRANSFUSION: A CLINICAL PRACTICE GUIDELINE FROM THE AABB. ANN INTERN MED. 2015. MANHIRE A, CHARIG M, CLELLAND C, ET AL. GUIDELINES FOR RADIOLOGICALLY GUIDED LUNG BIOPSY. THORAX. 2003. MAHADY SE, POLEKHINA G, WOODS RL, ET AL. ASSOCIATION BETWEEN CKD AND MAJOR HEMORRHAGE IN OLDER PERSONS: DATA FROM THE ASPIRIN IN REDUCING EVENTS IN THE ELDERLY RANDOMIZED TRIAL. KIDNEY INTERNATIONAL REPORTS. 2023. DIAZ-FUENTES G, BAJANTRI B, ADRISH M. SAFETY OF BRONCHOSCOPY IN PATIENTS WITH ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION. RESPIRATION. 2016. DIAZ-GUZMAN E, VADI S, MINAI OA, GILDEA TR, MEHTA AC. SAFETY OF DIAGNOSTIC BRONCHOSCOPY IN PATIENTS WITH PULMONARY HYPERTENSION. RESPIRATION. 2009. SCHULMAN LL, SMITH CR, DRUSIN R, ROSE EA, ENSON Y, REEMTSMA K. UTILITY OF AIRWAY ENDOSCOPY IN THE DIAGNOSIS OF RESPIRATORY COMPLICATIONS OF CARDIAC TRANSPLANTATION. CHEST. 1988.
IT WAS REPORTED THAT A PATIENT EXPIRED 7 DAYS AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE DUE TO BLEEDING AND SUBSEQUENT COMPLICATIONS. THE PATIENT HAD BEEN EXPERIENCING MILD HEMOPTYSIS FOR SEVERAL WEEKS PRIOR TO THE PROCEDURE. MEDICAL HISTORY INCLUDED LONGSTANDING INTERSTITIAL LUNG DISEASE, POSITIVE SCL-70 ANTIBODY, MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE (MGUS), RENAL CELL CARCINOMA, PARTIAL NEPHRECTOMY, CHRONIC KIDNEY DISEASE (CKD) STAGE IV, AND IMMUNE THROMBOCYTOPENIC PURPURA (ITP) WITH CHRONIC THROMBOCYTOPENIA. PLATELET COUNTS RANGED BETWEEN 46-63K PLATELETS/MICROLITER DURING THE LAST 6 MONTHS. THE BIOPSY TARGET LESION WAS 2 CM, HOWEVER THE SPECIMEN SHOWED INVOLVEMENT OF THE MAJORITY OF THE LEFT LOWER LOBE (LLL). DURING THE INITIAL PROCEDURE, THE PHYSICIAN BIOPSIED A 13 MM LESION IN THE LLL OUTER PERIPHERY. THE DISTANCE OF THE LESION TO THE PLEURA WAS 2 MM. THE PROCEDURE WAS COMPLETED WITHOUT ISSUES. A 21G NEEDLE (4 PASSES), CYTOLOGY BRUSH, AND A 1.8 MM BIOPSY FORCEPS WERE UTILIZED DURING THE BIOPSY. BLEEDING IN THE LUNGS DID NOT APPEAR UNTIL POST BIOPSY WHEN THE PATIENT EXPERIENCED A GRADE 1 HEMORRHAGE THAT WAS CONTROLLED WITH COLD SALINE AND THE BLEEDING STOPPED. THE PATIENT WAS SUCCESSFULLY EXTUBATED AND WAS TAKEN TO THE POST-OP AREA WHERE MODERATE AMOUNTS OF BLOODY SPUTUM CONTINUED. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO ICU FOR OBSERVATION. THE NEXT DAY, THE HEMOPTYSIS WORSENED. BRONCHOSCOPY WAS PERFORMED AND AN ENDOBRONCHIAL BLOCKER WAS PLACED. THE PATIENT ALSO UNDERWENT A SUCCESSFUL EMPIRIC BRONCHIAL ARTERY EMBOLIZATION. THE NEXT DAY, THE BRONCHIAL BLOCKER WAS REMOVED DURING A REPEAT BRONCHOSCOPY, AND AN ENDOBRONCHIAL CLOT WAS REMOVED. THE PATIENT¿S HEMORRHAGE RETURNED AND AN ENDOBRONCHIAL BLOCKER HAD TO BE PLACED AGAIN. PULMONARY ANGIOGRAM SHOWED NO BLEEDING FROM THE BRONCHIAL OR PULMONARY ARTERY. LATER THAT NIGHT, THE PATIENT STARTED TO HAVE DIFFICULTY VENTILATING AND WAS TAKEN TO THE OR FOR CLOT REMOVAL. LATER, CLOT REMOVAL FROM THE PATIENT¿S ENDOTRACHEAL TUBE AND DISTAL TRACHEA LED TO REPEAT HEMORRHAGE. THE PATIENT UNDERWENT AN EMERGENT LEFT LOWER LOBECTOMY. AFTER THE SUCCESSFUL LOBECTOMY, THE PATIENT CLINICALLY IMPROVED; HOWEVER, WAS NOT ABLE TO BE EXTUBATED IN THE NEXT 48 HOURS. THE HOSPITAL STAY WAS THEN COMPLICATED BY ACUTE KIDNEY INJURY (AKI) REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). THE PATIENT DEVELOPED SEPTIC SHOCK AND DIED 7 DAYS AFTER THE INITIAL BIOPSY. THE PULMONOLOGIST DID NOT ATTRIBUTE THE ION SYSTEM OR PRODUCTS USED DURING THE PROCEDURE TO THE COMPLICATIONS LEADING TO THE PATIENT'S DEATH, BUT TO THE PATIENT'S AGE AND POOR HEALTH. PER THE PHYSICIAN, THIS EVENT WAS LIKELY TO OCCUR REGARDLESS OF THE BIOPSY MODALITY USED. THE PHYSICIAN REPORTED THE BLEEDING WAS CAUSED BY THE BIOPSY THAT WAS REQUIRED FOR A DIAGNOSIS OF A CARCINOMA AND THAT THE BLEEDING LIKELY CAME FROM MALIGNANT TISSUE IN THE LLL AND / OR FROM VENOUS CONGESTION CAUSED BY THE PATIENT¿S LONG STANDING INTERSTITIAL LUNG DISEASE (ILD). THERE WAS NO MALFUNCTION OF ANY ION PRODUCTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491069 | ION | SYSTEM CART | EOQ | INTUITIVE SURGICAL, INC | 380748-60 | N/A | 00886874116234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | ION ENDOLUMINAL SYSTEM. |