BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR 3D ANNULOPLASTY RING

    MDR report key: 10160910 · Received June 16, 2020

    Report

    Report Number
    2025587-2020-01936
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    October 18, 2018
    Report Date
    June 16, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K101212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LOULMET DF ET AL. CAN COMPLEX MITRAL VALVE REPAIR BE PERFORMED WITH ROBOTICS? AN INSTITUTION¿S EXPERIENCE UTILIZING A DEDICATED TEAM APPROACH IN 500 PATIENTS. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2019; 56(3):470-478. DOI: 10.1093/EJCTS/EZZ029. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A PROSPECTIVE STUDY INTO ROBOTIC ENDOVASCULAR SURGERY FOR MITRAL VALVE REPAIR OF VARIOUS COMPLEXITY. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MAY 2011 AND AUGUST 2017. THE STUDY POPULATION INCLUDED 500 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 61 YEARS), 31 OF WHICH WERE IMPLANTED WITH MEDTRONIC 3D CONTOUR TRICUSPID ANNULOPLASTY RINGS (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 3 DEATHS OCCURRED. ONE PATIENT DIED IN THE HOSPITAL DUE TO UNEXPLAINED CARDIAC ARREST ON POSTOPERATIVE DAY 4. TWO OTHER PATIENTS DIED AFTER DISCHARGE FROM THE HOSPITAL WITHIN 30 DAYS OF SURGERY, ONE FROM PULMONARY EMBOLI AND ONE FROM BRAIN HEMORRHAGE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE (6 PATIENTS EXPERIENCED A NEUROLOGICAL EVENT, 1 PATIENT SUFFERING FROM PERMANENT NEUROLOGICAL DEFICIT), CONVERSION TO MITRAL VALVE REPLACEMENT (FOR A CALCIFIED POSTERIOR LEAFLET OR ADVANCED RHEUMATIC DISEASE), REDO MITRAL VALVE REPAIR, PERMANENT PACEMAKER IMPLANT, HAEMOTHORAX, RIGHT VENTRICULAR ASSIST DEVICE IMPLANT, PROLONGED VENTILATION, MODERATE RESIDUAL MITRAL REGURGITATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623900 CONTOUR 3D ANNULOPLASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 690R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention| S