BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG COMPOSITE RING

    MDR report key: 10371636 · Received August 6, 2020

    Report

    Report Number
    2025587-2020-02515
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    April 30, 2019
    Report Date
    August 6, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K061127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KODA Y ET AL. MID-TERM OUTCOMES OF SIMULTANEOUS MITRAL VALVE REPAIR IN PATIENTS WITH MIRAL REGURGITATION AND CONCOMITANT ANNULO-AORTIC ECTASIA. GENERAL THORACIC AND CARDIOVASCULAR SURGERY. 2019; 67:1014-1020. DOI: 10.1007/S11748-019-01129-Z 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 RETROSPECTIVE STUDY INTO THE SHORT-TERM OUTCOMES OF SIMULTANEOUS MITRAL VALVE REPAIR IN PATIENTS WITH MITRAL REGURGITATION AND CONCOMITANT ANNULO-AORTIC ECTASIA. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2007 AND MARCH 2018. THE STUDY POPULATION INCLUDED 26 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 46 YEARS, MEAN WEIGHT 56 KG), 12 OF WHOM WERE IMPLANTED WITH MEDTRONIC CG FUTURE ANNULOPLASTY RINGS (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, THE REPORTED 3-YEAR SURVIVAL RATE WAS 95.7%, MEANING THAT ONE DEATH OCCURRED. NO FURTHER DETAILS WERE PROVIDED ABOUT THE DEATHS, AND MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANT FOR SICK SINUS SYNDROME, COMPLETE HEART BLOCK, ATRIAL FIBRILLATION; CONCOMITANT MAZE PROCEDURE FOR ATRIAL FIBRILLATION; MEDIASTINITIS; LOW CARDIAC OUTPUT SYNDROME; SEVERE MITRAL REGURGITATION; SEVERE AORTIC 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
    838741 CG COMPOSITE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 638R

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention