BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 19121674 · Received April 16, 2024

    Report

    Report Number
    2955842-2024-13478
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 19, 2024
    Report Date
    March 19, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 20-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. THE INITIAL STROKE SYMPTOM WAS ALTERED MENTAL STATUS BUT LATER MANIFESTED AS COMPLETE PARALYSIS ON THE ONE SIDE AND APHASIC. THE STROKE WAS DENSE AND THE PATIENT DID NOT RECOVER. THE PATIENT WAS DISCHARGED UNDER HOSPICE CARE TO A REHAB FACILITY. THE PATIENT OUTCOME WAS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WERE RELEVANT TO THE REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) CONDUCTED A REVIEW OF THE EVENT INFORMATION. PER THE MSO, THE FOLLOWING WAS NOTED: "A 78-YEAR-OLD FEMALE UNDERWENT AN ION ENDOLUMINAL BIOPSY. AFTER THE PROCEDURE, A CHEST X-RAY REVEALED A PNEUMOTHORAX FOR WHICH A CHEST TUBE WAS PLACED. THE PATIENT WAS DIAGNOSED WITH A STROKE ON WORKUP FOR AN ALTERED SENSORIUM IN RECOVERY. BRONCHOSCOPY AND BIOPSY IS A MINIMALLY INVASIVE PROCEDURE WITH A LOW COMPLICATION RATE AND RARELY ASSOCIATED FATAL COMPLICATIONS. IN A MULTICENTER PROSPECTIVE STUDY OF (B)(4) BRONCHOSCOPIES THE TOTAL NUMBER OF COMPLICATIONS WAS REPORTED TO BE (B)(4) WITH (B)(4)TRANSIENT ISCHEMIC ATTACKS AND (B)(4) TOTAL DEATHS BUT NO STROKES. ANOTHER MULTICENTER STUDY REPORTED (B)(4)COMPLICATIONS WITH NO STROKES AND NO DEATHS ASSOCIATED WITH (B)(4) CASES. A RECENT PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF (B)(4) BRONCHOSCOPIES REPORTED (B)(4) ASSOCIATED DEATH(B)(4) AND NO STROKES. ANOTHER PROSPECTIVE SERIES OF (B)(4)ION PROCEDURES REPORTED (B)(4). THE RISK OF STROKE ASSOCIATED WITH GENERAL ANESTHESIA HAS BEEN REPORTED TO VARY FROM (B)(4) IN NON-CARDIAC, NON-NEUROLOGIC, AND NON-MAJOR SURGERY AND AS HIGH AS(B)(4) IN THE SETTING OF BRAIN OR HIGH-RISK CARDIOVASCULAR SURGERY. BASED ON THE AVAILABLE DATA THE STROKE WAS LIKELY PROCEDURE RELATED. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT, OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION TO SUGGEST IT WAS DEVICE RELATED. BASED ON THE AVAILABLE DATA THE REPORTED PNEUMOTHORAX IS PROCEDURE RELATED. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT OR ACCESSORIES ASSOCIATED WITH THE REPORTED COMPLICATION TO SUGGEST THE EVENT WAS DEVICE RELATED. PNEUMOTHORAX IS A KNOWN COMPLICATION OF BRONCHOSCOPY. ONE PROSPECTIVE MULTICENTER REGISTRY STUDY OF BRONCHOSCOPIC BIOPSIES OF PERIPHERAL LUNG LESIONS REPORTED (B)(4) PNEUMOTHORACES IN (B)(4) CASES REFLECTING A RATE OF (B)(4). ANOTHER PROSPECTIVE MULTICENTER INTERNATIONAL STUDY OF NAVIGATIONAL BRONCHOSCOPY IN (B)(4) SUBJECTS REPORTED A TOTAL PNEUMOTHORAX RATE OF (B)(4) AND A RATE OF (B)(4) REQUIRING HOSPITALIZATION OR INTERVENTION. A RECENT META-ANALYSIS OF NAVIGATIONAL BRONCHOSCOPY IN (B)(4) PATIENTS REPORTED A PNEUMOTHORAX RATE OF (B)(4). A CASE SERIES OF ION ROBOTIC ASSISTED BRONCHOSCOPIES PUBLISHED AFTER THE META-ANALYSIS INCLUDING (B)(4) CASES REPORTED A PNEUMOTHORAX RATE OF(B)(4) WITH A TOTAL OF (B)(4) PATIENTS REQUIRING A CHEST TUBE. --FACCIOLONGO N, PATELLI M, GASPARINI S, ET AL. INCIDENCE OF COMPLICATIONS IN BRONCHOSCOPY. MULTICENTREPROSPECTIVE 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. --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. --KOPS SEP, HEUS P, KOREVAAR DA, ET AL. DIAGNOSTIC YIELD AND SAFETY OF NAVIGATION BRONCHOSCOPY: A SYSTEMATIC REVIEW AND META-ANALYSIS. LUNG CANCER. 2023. --BATEMAN BT, SCHUMACHER HC, WANG S, SHAEFI S, BERMAN MF. PERIOPERATIVE ACUTE ISCHEMIC STROKE IN NONCARDIAC AND NONVASCULAR SURGERY: INCIDENCE, RISK FACTORS, AND OUTCOMES. ANESTHESIOLOGY. 2009. --SELIM M. PERIOPERATIVE STROKE. NEW ENGLAND JOURNAL OF MEDICINE. 2007."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT HAD DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT AND HOSPITALIZATION. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO DELAYS. A CHEST X-RAY POST-PROCEDURE IDENTIFIED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE PATIENT HAD NO SYMPTOMS RELATED TO THE PNEUMOTHORAX. HOWEVER, THE PATIENT REPORTEDLY DID EXHIBIT ALTERED MENTAL STATUS. A HEAD CT SCAN AND MRI CONFIRMED A STROKE. THE PATIENT REMAINS INTUBATED AND HOSPITALIZED. THE PHYSICIAN BELIEVES THAT THE PNEUMOTHORAX WAS PROCEDURE-RELATED AND WOULD HAVE LIKELY OCCURRED VIA ANOTHER MODALITY. THE PHYSICIAN REPORTED THAT THE PATIENT WAS DIAGNOSED WITH ADENOCARCINOMA AND IT IS POSSIBLE THAT THE PATIENT HAS UNDERLYING HYPERCOAGULABILITY RELATED TO CANCER. THE PHYSICIAN BELIEVED THAT THE STROKE WAS NOT ION-RELATED, AND WAS ATTRIBUTED TO ANESTHESIA, HYPOTENSION, HYPOPERFUSION OR THE CANCER-RELATED HYPERCOAGULABILITY. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892562 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-63 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.