BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8586228 · Received May 7, 2019

    Report

    Report Number
    2025587-2019-01482
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    June 14, 2018
    Report Date
    May 7, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SALEMI A ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN THE SETTING OF LEFT ATRIAL APPENDAGE THROMBUS. INTERACT CARDIOVASC THORAC SURG. 2018 DEC 1;27(6):842-849. DOI: 10.1093/ICVTS/IVY189. ADVANCE ACCESS PUBLICATION 2018 JUN 14. EARLIEST DATE OF PUBLICATION 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. (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 CLINICAL OUTCOMES FOR PATIENTS WITH A LEFT ATRIAL APPENDAGE THROMBUS OR SPONTANEOUS ECHO CONTRAST WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN (B)(6) 2009 AND (B)(6) 2014. THE STUDY POPULATION INCLUDED 369 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 84 YEARS), 10 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 90 DEATHS OCCURRED WITHIN ONE-YEAR POST IMPLANT. 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: CONVERSION TO OPEN HEART SURGERY, EMERGENT CARDIOPULMONARY BYPASS, EMERGENT INTRA-AORTIC BALLOON PUMP PLACEMENT, MYOCARDIAL INFARCTION, STROKE, TRANSIENT ISCHEMIC ATTACK, MAJOR AND LIFE-THREATENING BLEEDING, AORTIC INSUFFICIENCY (GREATER THAN OR EQUAL TO MODERATE), AND VASCULAR ACCESS COMPLICATIONS WITH TREATMENT (SPECIFIC INTERVENTIONS NOT REPORTED). 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
    379161 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention