BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7715215 · Received July 24, 2018

    Report

    Report Number
    2025587-2018-01846
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    March 19, 2012
    Report Date
    October 3, 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: SINNING JM ET AL. AORTIC REGURGITATION INDEX DEFINES SEVERITY OF PERI-PROSTHETIC REGURGITATION AND PREDICTS OUTCOME IN PATIENTS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. J AM COLL CARDIOL. 2012 MAR 27;59(13):1134-41. DOI: 10.1016/J.JACC.2011.11.048. EPUB 2012 MAR 19. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 ASSESSMENT OF PERI-PROSTHETIC AORTIC REGURGITATION (PERIAR) DURING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND TO DECIPHER THE IMPACT OF THIS PERI-PROCEDURAL PARAMETER ON OUTCOME. ALL DATA WERE COLLECTED FROM A SINGLE CENTER, HOWEVER A DATE RANGE OF WHEN THE STUDY WAS PERFORMED WAS NOT INCLUDED IN THE ARTICLE. THE STUDY POPULATION INCLUDED 146 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80.5±6.6 YEARS; MEAN WEIGHT 70 KG), ALL OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE. NO SERIAL NUMBERS WERE PROVIDED. INFORMATION ABOUT THE CAUSE OF DEATH WAS OBTAINED FROM THE TREATING HOSPITAL, REFERRING CARDIOLOGIST, OR GENERAL PRACTITIONER. AMONG ALL PATIENTS, 49 DEATHS OCCURRED: 10 PATIENTS DIED WITHIN THE FIRST 30 DAYS, AND 39 PATIENTS DIED DURING FOLLOW-UP OF UP TO 1 YEAR. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, MINOR AND MAJOR VASCULAR COMPLICATIONS, MYOCARDIAL INFARCTION, STROKE, MILD/MODERATE/SEVERE PERIAR, AND INCREASED LEFT VENTRICULAR END-DIASTOLIC PRESSURE. 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
    556739 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention