BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 11136781 · Received January 7, 2021

    Report

    Report Number
    2025587-2021-00067
    Event Type
    Death
    Date Received
    January 7, 2021
    Date of Event
    November 26, 2020
    Report Date
    January 7, 2021
    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: OOMS JF ET AL. SIMPLIFIED TRANS-AXILLARY AORTIC VALVE REPLACEMENT UNDER LOCAL ANESTHESIA - A SINGLE CENTER EARLY EXPERIENCE. CARDIOVASC REVASC MED. 2020 NOV 26;S1553-8389(20)30781-8. DOI: 10.1016/J.CARREV.2020.11.025. 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 THE PATIENT OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT VIA A SIMPLIFIED TRANS-AXILLARY APPROACH USING ONLY LOCAL ANESTHESIA, ULTRASOUND GUIDED AXILLARY ARTERY ACCESS, AND ARTERIOTOMY CLOSURE WITH NON-MEDTRONIC VASCULAR CLOSURE DEVICES. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN JULY 2018 AND APRIL 2020. THE STUDY POPULATION INCLUDED 35 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 79 YEARS. ALL PATIENTS WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER VALVES: EVOLUT R (31) OR EVOLUT PRO (3). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ONE PROCEDURAL DEATH OCCURRED DUE TO AORTIC ROOT RUPTURE AFTER VALVE IMPLANT AND A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION DUE TO TOTAL ATRIOVENTRICULAR BLOCK, NEED FOR SECOND TRANSCATHETER VALVE IMPLANT, STROKE, TRANSIENT ISCHEMIC ATTACK, MODERATE PARAVALVULAR LEAK, TAMPONADE, NON-ACCESS SITE LIFE-THREATENING BLEEDING OR MAJOR VASCULAR COMPLICATION, ACCESS SITE RELATED VASCULAR COMPLICATION (MAJOR) OR BLEEDING (LIFE-THREATENING OR MAJOR), HEMATOMA, BLOOD TRANSFUSIONS, AND REINTERVENTION AT THE ACCESS SITE (POST-DILATION). IN ONE CASE THE PROCEDURE WAS ABORTED BECAUSE AN AXILLARY ARTERY DISSECTION OCCURRED WHILE ADVANCING THE DELIVERY CATHETER SYSTEM, WHICH CAUSED A STROKE AND LIFE-THREATENING BLEEDING THAT WAS TREATED WITH MANUAL COMPRESSION AND MULTIPLE BLOOD TRANSFUSIONS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS 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
    28266 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death