BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 19758343 · Received July 17, 2024

    Report

    Report Number
    2955842-2024-17039
    Event Type
    Death
    Date Received
    July 17, 2024
    Date of Event
    March 14, 2024
    Report Date
    June 17, 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
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 THE PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY FOR A LARGE 6-7CM LUNG MASS. MASSIVE HEMOPTYSIS DEVELOPED AFTER A CRYOBIOPSY. A CODE WAS CALLED AND BLOOD TRANSFUSIONS WERE ADMINISTERED; HOWEVER, EXTENDED RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT DIED. POST PROCEDURE IT WAS NOTED THE PATIENT HAD LOW PLATELETS. THE USE OF A CRYOPROBE THROUGH THE ION SYSTEM IS OFF LABEL. EFFORTS AT OBTAINING FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL THUS FAR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. BASED ON THE AVAILABLE DATA THE REPORTED ADVERSE EVENT WAS PROCEDURE RELATED AS BLEEDING IS A RARE, BUT KNOWN COMPLICATION OF LUNG BIOPSIES. 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. BRITISH THORACIC SOCIETY (BTS) GUIDELINES FOR FLEXIBLE BRONCHOSCOPY RECOMMENDS TO LIASE 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. 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. BLANK MDR FIELDS: SECTION A2: THE PATIENT WAS REPORTED TO BE IN THEIR "80'S" YEARS. 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. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: A4, B2 DATE OF DEATH, B6, B7, E1-3, H2, H11. SECTION B5 ADDITIONAL INFORMATION: THE PATIENT WAS ON WARFARIN WHICH WAS HELD FOR 8 DAYS PRIOR TO THE PROCEDURE. THE LESION WAS 14MM X 13MM IN THE LEFT LOWER LOBE SUPERIOR SEGMENT, 3MM FROM THE MEDIAL PLEURA. DURING THE PROCEDURE 6 CRYOPROBE BIOPSIES WERE PERFORMED. MASSIVE HEMOPTYSIS OCCURRED; THERE WAS BRISK BLEEDING, QUANTIFIED BY THE PROCEDURALIST AS GREATER THAN 300ML WHICH RESULTED IN THE INABILITY TO VISUALIZE. THE BLEEDING LUNG WAS ISOLATED BY ADVANCING THE ETT TO THE RIGHT MAINSTEM. A CODE WAS CALLED AND MASSIVE TRANSFUSIONS OF 9 UNITS PRBCS, 8 UNITS FFP, 3 UNITS PLATELETS, AND 3 UNITS CRYOPRECIPITATE. THE CODE LASTED OVER AN HOUR AND THE PATIENT ACHIEVED RETURN OF SPONTANEOUS CIRCULATION AFTER RESUSCITATION, AND BRONCHIAL ARTERY EMBOLIZATION WAS PERFORMED. THE PATIENT EXPIRED THE NEXT DAY. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO HYPOXEMIA FROM BLOOD IN THE AIRWAY AND THE INABILITY TO OXYGENATE RESULTING IN PULSELESS ELECTRICAL CARDIAC ARREST. A REVIEW OF THE NEW EVENT DETAILS WAS PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL BIOPSY OF THE LEFT LUNG COMPLICATED BY MASSIVE HEMOPTYSIS AFTER 6 CRYOPROBE (OFF LABEL USE) BIOPSIES WERE COMPLETED. THE RIGHT MAINSTEM BRONCHUS WAS INTUBATED. A CODE WAS INITIATED AND MASSIVE TRANSFUSIONS WITH MULTIPLE BLOOD PRODUCTS AS OUTLINED WERE INFUSED. ROSC WAS ACHIEVED AFTER RESUSCITATIVE EFFORTS AND THE PATIENT UNDERWENT URGENT BRONCHIAL ARTERY EMBOLIZATION PRIOR TO BEING TRANSFERRED TO THE ICU FOR ONGOING MANAGEMENT. THE PATIENT DIED THE FOLLOWING DAY. PLATELET COUNT WAS LOW AT 44 AND CLOTTING TIME WAS NOTED TO BE ABNORMAL AFTER DEATH. THERE IS NO MALFUNCTION OF THE ION SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE AVAILABLE DATA THE EVENT WAS PROCEDURE RELATED AND NOT DEVICE RELATED IN THE SETTING OF THROMBOCYTOPENIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL BIOPSY OF A 6-7CM LESION IN THE RIGHT LUNG, THE PATIENT EXPIRED. NO ISSUES OCCURRED WITH THE ION SYSTEM. THE SITE ION COORDINATOR REPORTED THAT WHILE THE PHYSICIAN WAS PERFORMING A CRYOBIOPSY WITH A THIRD PARTY CRYOPROBE, MASSIVE HEMOPTYSIS OCCURRED. A CODE WAS CALLED AND APPROXIMATELY 5 UNITS OF BLOOD WERE TRANSFUSED. RESUSCITATION ACTIVITIES WERE RENDERED FOR OVER AN HOUR BUT WERE NOT SUCCESSFUL. THE FAMILY OPTED NOT TO HAVE AN AUTOPSY PERFORMED. AFTER THE PATIENT EXPIRED, IT WAS DETERMINED THAT THE PATIENT'S PLATELET COUNT WAS LOW AND THEIR CLOTTING TIME WAS ABNORMAL.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503546 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death| R ION ENDOLUMINAL SYSTEM.