BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 10786286 · Received November 4, 2020

    Report

    Report Number
    2025587-2020-03431
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    September 21, 2018
    Report Date
    November 4, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VLASTRA W ET AL. PREDICTORS, INCIDENCE AND OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION COMPLICATED BY STROKE ¿ FROM THE CENTER-COLLABORATION. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY; 2018. 72(13 SUPP B) P. B31, TCT-71. PRESENTED AT TCT 2018 ON SEPTEMBER 21, 2018. DOI: NOT AVAILABLE. THE ABSTRACT AND PRESENTATION SLIDE DECK PDFS WERE ATTACHED TO THE REPORT. DATE OF PRESENTATION 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. 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 ABSTRACT AND PRESENTATION SLIDE DECK REGARDING THE INCIDENCE AND PREDICTORS OF STROKE AFTER TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND AN EVALUATION OF THE SHORT-TERM OUTCOMES OF PATIENTS WITH STROKE. ALL DATA WERE COLLECTED FROM AN INTERNATIONAL COLLABORATION AMONG THREE NATIONAL REGISTRIES AND SEVEN PROSPECTIVE CLINICAL TRIALS BETWEEN 2007 AND 2018. THE STUDY POPULATION INCLUDED 12,381 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS. OF THOSE, 6,142 PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. THE MORTALITY RATE FOR PATIENTS WHO HAD A STROKE WITHIN 30 DAYS AFTER TAVI WAS 25%, WHILE THE MORTALITY RATE FOR PATIENTS WHO DID NOT HAVE A STROKE WITHIN 30 DAYS AFTER TAVI WAS 5%. MULTIPLE MANUFACTURERS TRANSCATHETER VALVES WERE IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS THAT OCCURRED WITHIN 30 DAYS AFTER TAVI INCLUDED: STROKE OR MAJOR STROKE (MEDIAN TIME BETWEEN TAVI AND STROKE WAS ONE DAY), TRANSIENT ISCHEMIC ATTACK, PERMANENT PACEMAKER IMPLANTATION, MYOCARDIAL INFARCTION, NEW-ONSET ATRIAL FIBRILLATION, AND MAJOR OR LIFE-THREATENING BLEEDING. IN ADDITION, IT WAS STATED THAT THE CUMULATIVE STROKE RATE INCREASED FROM 2.4% AT 30 DAYS TO 5% AT ONE YEAR AFTER TAVI. 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
    1251377 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R