BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 9373472 · Received November 25, 2019

    Report

    Report Number
    2025587-2019-03594
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 25, 2019
    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: SCHEWEL J ET AL. IMPACT OF PULMONARY HYPERTENSION HEMODYNAMIC STATUS ON LONG-TERM OUTCOME AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2019 NOV 11;12(21):2155-2168. DOI: 10.1016/J.JCIN.2019.08.031. 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 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 THE PROGNOSTIC IMPACT AND DEVELOPMENT OF PULMONARY HYPERTENSION (PH) IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM SINGLE CENTER BETWEEN JULY 2008 AND NOVEMBER 2017. THE STUDY POPULATION INCLUDED 1,400 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81 YEARS), WHO WERE IMPLANTED WITH DEVICES FROM SEVERAL MANUFACTURERS INCLUDING AN UNSPECIFIED NUMBER OF MEDTRONIC COREVALVE, EVOLUT R, OR EVOLUT PRO BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS THERE WERE SIX IMMEDIATE PROCEDURAL DEATHS, 65 ALL-CAUSE DEATHS AT DISCHARGE, 257 ALL-CAUSE MORTALITY AT ONE YEAR POST-IMPLANT, AND 458 ALL-CAUSE MORTALITY AT FOUR YEARS POST-IMPLANT. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: SEVERE PROSTHETIC REGURGITATION, SEVERE PARAVALVULAR LEAK (PVL), MAJOR STROKE, MAJOR VA SCULAR COMPLICATIONS, LIFE THREATENING/DISABLING BLEEDING, ARRHYTHMIA REQUIRING NEW PERMANENT PACEMAKER, SECOND PROSTHETIC VALVE IMPLANT, CONVERSION TO OPEN SURGERY. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164299 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R