BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 10485735 · Received September 2, 2020

    Report

    Report Number
    2025587-2020-02738
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    March 27, 2014
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DE BONIS M ET AL. VERY LONG-TERM DURABILITY OF THE EDGE-TO-EDGE REPAIR FOR ISOLATED ANTERIOR MITRAL LEAFLET PROLAPSE: UP TO 21 YEARS OF CLINICAL AND ECHOCARDIOGRAPHIC RESULTS. J THORAC CARDIOVASC SURG. 2014 NOV;148(5):2027-32. DOI: 10.1016/J.JTCVS.2014.03.041. EPUB 2014 MAR 27. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING AN ASSESSMENT OF THE LONG-TERM CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES OF THE EDGE-TO-EDGE REPAIR TECHNIQUE COMBINED WITH MITRAL ANNULOPLASTY IN PATIENTS WITH MITRAL REGURGITATION (MR) DUE TO ISOLATED PROLAPSE OR FLAIL OF THE ANTERIOR LEAFLET. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 1991 AND 2004. THE STUDY POPULATION INCLUDED 139 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 54 YEARS. OF THOSE, 6 WERE IMPLANTED WITH MEDTRONIC DURAN ANCORE ANNULOPLASTY RINGS. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 16 DEATHS OCCURRED AFTER HOSPITAL DISCHARGE (7 CARDIAC RELATED, 9 NON-CARDIAC RELATED). THE CAUSES OF CARDIAC DEATH INCLUDED: ACUTE AORTIC DISSECTION (1), SUDDEN DEATH (2), CEREBRAL HEMORRHAGE (1), MYOCARDIAL INFARCTION (1), AND UNKNOWN (2). THE STUDY USED NON-MEDTRONIC ANNULOPLASTY RINGS IN ADDITION TO THE DURAN ANCORE. THE TYPE OF ANNULOPLASTY RING IMPLANTED IN EACH PATIENT WHO DIED WAS NOT REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, POST-OPERATIVE ADVERSE EVENTS INCLUDED: REOPERATION/MITRAL VALVE REPLACEMENT DUE TO SEVERE RECURRENT MR (1 MONTH TO 9 YEARS AFTER THE INITIAL REPAIR); PERMANENT PACEMAKER IMPLANTATION DUE TO UNSPECIFIED RHYTHM DISTURBANCES; RE-EXPLORATORY SURGERY DUE TO BLEEDING; STROKE (MAJOR OR MINOR CEREBRAL HEMORRHAGE); MYOCARDIAL INFARCTION; PERICARDIAL EFFUSION; PERICARDITIS; RECURRENT MR DUE TO MITRAL ENDOCARDITIS, NEW PROLAPSE, OR RESTRICTED MOTION FROM LEAFLET FIBROSIS; LOW OUTPUT SYNDROME; PROLONGED VENTILATORY SUPPORT (MORE THAN 48 HOURS); PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY STENTING FOR ANGINA; AORTIC DISSECTION (NO TREATMENT OR INTERVENTION REPORTED); AND STERNAL REWIRING. 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
    949862 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention