BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 8975702 · Received September 9, 2019

    Report

    Report Number
    2025587-2019-02763
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    March 23, 2018
    Report Date
    September 9, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LI B ET AL. LONG-TERM OUTCOMES OF MITRAL VALVE ANNULOPLASTY VERSUS SUBVALVULAR SPARING REPLACEMENT FOR SEVERE ISCHEMIC MITRAL REGURGITATION. CARDIOL J. 2019;26(3):265-274. DOI: 10.5603/CJ.A2018.0006. EPUB 2018 MAR 23. 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 THE 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 VIA LITERATURE REGARDING AN EVALUATION OF THE LONG-TERM OUTCOMES IN PATIENTS WITH SEVERE CHRONIC ISCHEMIC MITRAL REGURGITATION WHO UNDERWENT MITRAL VALVE ANNULOPLASTY (MVA) OR SUBVALVULAR SPARING MITRAL VALVE REPLACEMENT (MVR). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2003 AND DECEMBER 2014. THE STUDY POPULATION INCLUDED 392 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 61 YEARS), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC DURAN ANCORE ANNULOPLASTY RINGS, MEDTRONIC MOSAIC BIOPROSTHETIC VALVES, MEDTRONIC HANCOCK II BIOPROSTHETIC VALVES, OR MEDTRONIC OPEN PIVOT MECHANICAL VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 62 DEATHS OCCURRED DURING FOLLOW-UP (MEDIAN FOLLOW-UP OF 53 MONTHS). OF THOSE, 53 WERE DUE TO CARDIAC CAUSES. NO OTHER DETAILS WERE REPORTED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: REOPERATION FOR BLEEDING, POST-OPERATIVE INTRA-AORTIC BALLOON PUMP SUPPORT, MODERATE MITRAL REGURGITATION (MVA AND MVR PATIENTS), SEVERE MITRAL REGURGITATION (MVA PATIENTS), PERIPROSTHETIC LEAK (MVR PATIENTS), AND DECREASED LEFT VENTRICULAR EJECTION FRACTION. IT WAS ALSO NOTED THAT 82 MVA PATIENTS AND 14 MVR PATIENTS EXPERIENCED MACCE (MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENT) DURING LONG-TERM FOLLOW-UP. MACCE INCLUDED: REPEAT REVASCULARIZATION AND MYOCARDIAL INFARCTION, STROKE, SUBSEQUENT MITRAL VALVE SURGERY, OR HOSPITALIZATION FOR HEART FAILURE. 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
    770664 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T510

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention