BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 10485076 · Received September 2, 2020

    Report

    Report Number
    2025587-2020-02732
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    November 20, 2009
    Report Date
    September 2, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DIBARDINO, ET AL. FOUR DECADES OF EXPERIENCE WITH MITRAL VALVE REPAIR: ANALYSIS OF DIFFERENTIAL INDICATIONS, TECHNICAL EVOLUTION, AND LONG-TERM OUTCOME. J THORAC CARDIOVASC SURG. 2010 JAN;139(1):76-83; DISCUSSION 83-4. DOI: 10.1016/J.JTCVS.2009.08.058. PMID: 19931098. AVAILABLE AHEAD OF PRINT NOV 20, 2009. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: DURAN ANCORE ANNULOPLASTY RING (PMA# K960356, PRODUCT CODE KRH), CG FUTURE BAND ANNULOPLASTY RING (PMA# K061127, PRODUCT CODE KRH). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 LONG-TERM OUTCOMES OF MITRAL VALVULOPLASTY PERFORMED BY A SINGLE SURGEON OVER A FOUR-DECADE PERIOD. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 1972 AND APRIL 2008. THE STUDY POPULATION INCLUDED 1503 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 60.3 YEARS), 178 OF WHOM WERE IMPLANTED WITH MEDTRONIC DURAN ANCORE ANNULOPLASTY RINGS AND 9 WERE IMPLANTED WITH MEDTRONIC CG FUTURE ANNULOPLASTY RINGS (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, OVERALL 30-DAY MORTALITY WAS 1.3% WITH OPERATIVE MORTALITY BY DECADE AT 0% IN THE 1970S, 1.8% IN THE 1980S, 1.4% IN THE 1990S AND 1.1% IN THE 2000S. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: ACUTE DISSECTION OF THE ASCENDING AORTA, MODERATE-SEVERE MITRAL REGURGITATION AND MODERATE-SEVERE MITRAL STENOSIS REQUIRING SURGICAL CORRECTION, SEVERE SYSTOLIC ANTERIOR LEAFLET MOTION AFTER REPAIR REQUIRING SURGICAL CORRECTION. 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
    948991 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR