BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7822492 · Received August 28, 2018

    Report

    Report Number
    2025587-2018-02257
    Event Type
    Death
    Date Received
    August 28, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 28, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HOLY EW ET AL. LONG-TERM DURABILITY AND HAEMODYNAMIC PERFORMANCE OF A SELF-EXPANDING TRANSCATHETER HEART VALVE BEYOND FIVE YEARS AFTER IMPLANTATION: A PROSPECTIVE OBSERVATIONAL STUDY APPLYING THE STANDARDISED DEFINITIONS OF STRUCTURAL DETERIORATION AND VALVE FAILURE. EUROINTERVENTION. 2018 JUL 20;14(4): E390-E396. DOI: 10.4244/EIJ-D-18-00041. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH 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. 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 DURABILITY AND PERFORMANCE OF SELF-EXPANDING TRANSCATHETER HEART VALVES BEYOND FIVE YEARS POST-IMPLANT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2007 AND DECEMBER 2011. THE STUDY POPULATION INCLUDED 152 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81 YEARS), ALL OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, A TOTAL OF 95 DEATHS OCCURRED WITH A MEDIAN TIME OF 3.4 YEARS FROM IMPLANT TO DEATH. OF THESE DEATHS, 66 WERE CONSIDERED CARDIOVASCULAR DEATHS DUE TO VARIOUS CAUSES SUCH AS PROCEDURE-RELATED COMPLICATIONS, STROKE, MYOCARDIAL INFARCTION, SUDDEN CARDIAC DEATH / ARRHYTHMIA, HEART FAILURE, OR UNKNOWN. OF THE 66 CARDIOVASCULAR DEATHS, SIX OCCURRED WITHIN 30 DAYS OF IMPLANT WHICH WERE CHARACTERIZED IN A SUPPLEMENTARY TABLE AS ¿PROCEDURE-RELATED (VASCULAR COMPLICATION, BLEEDING, AORTIC OR VENTRICULAR RUPTURE)¿. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE DEATHS - MOST SPECIFICALLY THE AORTIC RUPTURE. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MODERATE TO SEVERE AORTIC REGURGITATION WITH INTERVENTION, MYOCARDIAL INFARCTION, MAJOR STROKE, MAJOR BLEEDING, MAJOR VASCULAR COMPLICATIONS, ACUTE KIDNEY INJURY, AND NEW PERMANENT PACEMAKER. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662404 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death