BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 10474743 · Received August 31, 2020

    Report

    Report Number
    2025587-2020-02715
    Event Type
    Death
    Date Received
    August 31, 2020
    Date of Event
    June 16, 2020
    Report Date
    August 31, 2020
    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: PIAYDA K ET AL. PERFORMANCE OF THE COREVALVE EVOLUT R AND PRO IN SEVERELY CALCIFIED ANATOMY: A PROPENSITY SCORE MATCHED ANALYSIS. HEART LUNG CIRC. 2020 JUN 16;S1443-9506(20)30265-1. DOI: 10.1016/J.HLC.2020.05.096. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PMA# P130021, PRO CODE NPT), EVOLUT PRO (PMA# P130021, PRO CODE NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 ARTICLE REGARDING AN ASSESSMENT OF THE PERFORMANCE OF THE EVOLUT R AND EVOLUT PRO IN PATIENTS WITH SEVERELY CALCIFIED NATIVE AORTIC VALVE ANATOMY. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2015 AND MARCH 2018. THE STUDY POPULATION INCLUDED 361 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 82 YEARS. ALL PATIENTS UNDERWENT TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH THE MEDTRONIC EVOLUT R (287) OR EVOLUT PRO (74). NO SERIAL NUMBERS WERE PROVIDED. ONE PATIENT, IDENTIFIED AS A (B)(6) YEAR OLD FEMALE, WAS TREATED WITH A 26 MM EVOLUT R WITH A REPORTED MEAN IMPLANTATION DEPTH OF 4.9 MM (5.2 MM AT THE NON-CORONARY CUSP AND 4.6 MM AT THE LEFT CORONARY CUSP). DURING VALVE IMPLANTATION, THE LEFT CORONARY ARTERY WAS OBSTRUCTED, AND RESCUE STENTING WITH OPEN-HEART SURGERY WAS UNSUCCESSFUL AND THE PATIENT DIED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THIS DEATH. AN ADDITIONAL 4 DEATHS OCCURRED WITHIN 30 DAYS AFTER TAVR. NO FURTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION; VALVE-IN-VALVE IMPLANTATION DUE TO SEVERE AORTIC REGURGITATION/PARAVALVULAR LEAK CAUSED BY VALVE DISLODGEMENT; STROKE OR TRANSIENT ISCHEMIC ATTACK; CONVERSION TO OPEN-HEART SURGERY; NEED FOR CARDIOPULMONARY RESUSCITATION; NEED FOR INTUBATION; NEED FOR MECHANICAL CIRCULATORY SUPPORT; MILD TO MODERATE AORTIC REGURGITATION/PARAVALVULAR LEAK; LIFE-THREATENING OR MAJOR BLEEDING; AND MAJOR VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENTS. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THE FOLLOWING: AN AUTOPSY WAS NOT PERFORMED ON THE (B)(6) YEAR OLD FEMALE PATIENT, BUT THE EVOLUT R WAS THE LIKELY CAUSE OF THE CORONARY OBSTRUCTION. THE CAUSE OF DEATH WAS PROCEDURE RELATED FOR ALL 4 PATIENTS WHO DIED WITHIN 30 DAYS AFTER TAVR. NO FURTHER DETAILS ARE ABLE TO BE PROVIDED. ALL PACEMAKER INDICATIONS AND VASCULAR COMPLICATIONS WERE PROCEDURE RELATED. NO EVOLUT R OR EVOLUT PRO VALVES WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936003 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death