BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 16010222 · Received December 19, 2022

    Report

    Report Number
    2955842-2022-16037
    Event Type
    Death
    Date Received
    December 19, 2022
    Date of Event
    November 21, 2022
    Report Date
    November 22, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE MYOCARDIAL INFARCTION CANNOT BE DETERMINED ALTHOUGH THE PHYSICIAN ATTRIBUTED THE COMPLICATION TO THE PATIENT¿S UNDERLYING PRE-EXISTING CONDITION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. ON (B)(6) 2022, PER AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ENGINEER, A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. ON (B)(6) 2022, A REVIEW OF THE EVENT INFORMATION WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER (MSO) AND PROVIDED THE FOLLOWING CONCLUSION: A PATIENT OF UNKNOWN AGE/GENDER AND UNKNOWN MEDICAL COMORBIDITIES UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY. THE PATIENT SUFFERED A MYOCARDIAL INFARCTION COMPLICATED BY A CARDIAC ARREST FOR WHICH 2 ROUNDS OF CARDIOPULMONARY RESUSCITATION AND EPINEPHRINE WERE ADMINISTERED. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE PATIENT WAS HOSPITALIZED. THE PATIENT DIED AFTER 6 DAYS DURING THE HOSPITALIZATION. THERE WAS NO MALFUNCTION OF THE ION, INSTRUMENTS OR ACCESSORIES. THE PHYSICIAN DID NOT THINK THE ION, INSTRUMENTS OR ACCESSORIES CONTRIBUTED TO THE MYOCARDIAL INFARCTION AND SUBSEQUENT HOSPITAL COURSE INCLUDING DEATH. ATTEMPTS WERE MADE TO OBTAIN FURTHER DETAILS FROM THE PATIENT CARE TEAM BUT NO FURTHER INFORMATION WAS MADE AVAILABLE. LARGE CASE SERIES OF BRONCHOSCOPY HAVE REPORTED MYOCARDIAL INFARCTION IS RARELY ASSOCIATED WITH BRONCHOSCOPY. ONLY 1 MYOCARDIAL INFARCTION EVENT WAS REPORTED IN 20,986 CASES AND NONE IN THE LARGEST NAVIGATIONAL BRONCHOSCOPY STUDY COMPLETED TO DATE WHICH INCLUDED 1,388 PATIENTS. BASED ON THE AVAILABLE DATA THERE IS NO CLEAR CAUSAL RELATIONSHIP BETWEEN THE ION ENDOLUMINAL LUNG BIOPSY, THE MYOCARDIAL INFARCTION AND SUBSEQUENT HOSPITAL COURSE INCLUDING DEATH. 1. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION AND WENT INTO CARDIAC ARREST. THE PROCEDURE WAS ABORTED. ADVANCED CARDIAC LIFE SUPPORT WAS IMPLEMENTED FOR 6 MINUTES AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED THEREAFTER. THE PATIENT DIED AFTER 6 DAYS DURING THE HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION TRANSBRONCHIAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND WENT INTO CARDIAC ARREST. THE PROCEDURE WAS ABORTED. ADVANCED CARDIAC LIFE SUPPORT WAS IMPLEMENTED FOR 6 MINUTES WITH 2 ROUNDS OF CARDIOPULMONARY RESUSCITATION AND EPINEPHRINE WAS ADMINISTERED. THE PATIENT HAD A RETURN OF SPONTANEOUS CIRCULATION THEREAFTER. THE PATIENT WAS REVIVED AND REQUIRED HOSPITALIZATION FOR 6 DAYS; UNFORTUNATELY, THE PATIENT THEN EXPIRED. PER THE PHYSICIAN, THERE WAS NO MALFUNCTION OF AN ION PRODUCT ASSOCIATED WITH THE EVENT. THE PHYSICIAN BELIEVED THAT THE ION OR INSTRUMENTS AND ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE EVENT; THIS WAS ATTRIBUTED TO PATIENT¿S UNDERLYING PRE-EXISTING CONDITION. THE CARDIAC ARREST COULD HAVE OCCURRED VIA ANOTHER MODALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097521 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown ION ENDOLUMINAL SYSTEM