BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 14044040 · Received April 7, 2022

    Report

    Report Number
    2955842-2022-10916
    Event Type
    Death
    Date Received
    April 7, 2022
    Report Date
    March 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE PATIENT DEATH ASSOCIATED WITH AN UNSTABLE MASSIVE HEMORRHAGE WAS CAUSED BY SUBCLAVIAN ARTERY INJURY FROM NECK CANNULATION DURING MV REPEAT REPAIR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE EVENT INFORMATION HAS BEEN REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO). PER THE MSO, "THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENTS IS NOT SUFFICIENT TO DRAW ANY CONCLUSIONS ABOUT THE POTENTIAL CAUSE OR CONTRIBUTION OF THE DA VINCI SYSTEM, INSTRUMENTATION, AND/OR ACCESSORIES TO THE PATIENT MORTALITY NOTED IN THE JOURNAL ARTICLE." THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, AND PROCEDURE AND INSTRUMENT DETAIL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿ROBOTIC MITRAL VALVE REPAIR: A DECADE OF EXPERIENCE WITH ECHOCARDIOGRAPHIC FOLLOW-UP,¿ IT IS NOTED THAT A PATIENT DEATH OCCURRED AS A RESULT OF AN UNSTABLE MASSIVE HEMORRHAGE CAUSED BY SUBCLAVIAN ARTERY INJURY FROM NECK CANNULATION DURING MITRAL VALVE (MV) REPEAT REPAIR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. REFER TO MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE PATIENT DEATH THAT OCCURRED FROM ACUTE EXPANSION OF A PREVIOUSLY UNDIAGNOSED SUBDURAL HEMATOMA. REFER TO MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE PATIENT DEATH THAT OCCURRED 2 WEEKS AFTER DISMISSAL OF UNKNOWN CAUSE. REFER TO MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) (THIS REPORT) FOR MDR SUBMISSION OF THE PATIENT DEATH ASSOCIATED WITH AN UNSTABLE MASSIVE HEMORRHAGE CAUSED BY SUBCLAVIAN ARTERY INJURY FROM NECK CANNULATION DURING MITRAL VALVE (MV) REPEAT REPAIR. REFER TO MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL INFORMATION REGARDING THE OPERATIVE COMPLICATIONS THAT REQUIRED READMISSION AND MEDICAL/SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    ON 09-MAR-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ¿ANNALS OF THORACIC SURGERY¿ JOURNAL ARTICLE TITLED, ¿ROBOTIC MITRAL VALVE REPAIR: A DECADE OF EXPERIENCE WITH ECHOCARDIOGRAPHIC FOLLOW-UP¿ (ARGHAMI, A., JAHANIAN, S., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 3 (0.4%) EARLY POSTOPERATIVE DEATHS. ONE PATIENT EXPERIENCED AN UNSTABLE MASSIVE HEMORRHAGE CAUSED BY SUBCLAVIAN ARTERY INJURY FROM NECK CANNULATION DURING MV REPEAT REPAIR. THE SECOND PATIENT DIED OF ACUTE EXPANSION OF A PREVIOUSLY UNDIAGNOSED SUBDURAL HEMATOMA AFTER SURGERY. THE THIRD PATIENT DIED 2 WEEKS AFTER DISMISSAL OF UNKNOWN CAUSE. THERE WERE 61 PATIENTS (7.2%) WITH EARLY READMISSION, MOST COMMONLY FOR ARRHYTHMIAS (TABLE 3).¿ ADDITIONALLY, THE FOLLOWING IS NOTED WITHIN THE ARTICLE: EARLY POSTOPERATIVE COMPLICATIONS OF ATRIAL FIBRILLATION OR ATRIAL FLUTTER OCCURRED IN 194 NINETY-FOUR PATIENTS WITHIN THE FIRST 30 DAYS. ADDITIONALLY, TWENTY-FOUR PATIENTS UNDERWENT REOPERATION WITH THE MOST COMMON REOPERATIONS INCLUDING EXPLORATION DUE TO BLEEDING IN 13 PATIENTS. THREE PATIENTS UNDERWENT REPEAT MITRAL VALVE REPAIR FOR RECURRENT MITRAL REGURGITATION (MR), A RUPTURED NEOCHORD WAS FOUND ON INTRAOPERATIVE FINDINGS SHOWED A RUPTURED NEOCHORD IN ONE PATIENT, A TEAR WAS FOUND IN THE P2 PLICATION SITE IN ONE PATIENT AND AN INTACT PREVIOUS REPAIR WITH NO ANOMALY IN ANOTHER PATIENT. THREE PATIENTS UNDERWENT GROIN EXPLORATION FOR FEMORAL NERVE PALSY, PERSISTENT GROIN PAIN, AND GROIN INCISIONAL SEROMA. OTHER EARLY REOPERATIONS INCLUDE A LOWER EXTREMITY FASCIOTOMY FOR COMPARTMENT SYNDROME, EVACUATION OF BREAST HEMATOMA, ENDOVASCULAR REPAIR OF AN AORTIC DISSECTION, REEXPLORATION, AND CLOSURE OF PERICARDIUM TO ADDRESS CARDIAC HERNIATION, AND REEXPLORATION FOR THORACOTOMY WORKING PORT WOUND DEHISCENCE AND SUBSEQUENT RIGHT LUNG HERNIATION. ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425332 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES