BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12139472 · Received July 8, 2021

    Report

    Report Number
    2025587-2021-02135
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    May 20, 2020
    Report Date
    July 8, 2021
    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: SEPPELT PC, ET AL. DYNAMICS OF CEREBRAL OXYGENATION DURING RAPID VENTRICULAR PACING AND ITS IMPACT ON OUTCOME IN TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION. CATHETER CARDIOVASC INTERV. 2021 JAN 1;97(1):E146-E153. DOI: 10.1002/CCD.28975. EPUB 2020 MAY 20. EARLIEST DATE OF PUBLISH 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 ARTICLE REGARDING THE DYNAMICS OF CEREBRAL OXYGEN SATURATION DURING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN NON-VENTILATED PATIENTS AND ITS IMPACT ON PROCEDURAL OUTCOME. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN JULY 2018 AND APRIL 2019. OF THE 50 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE 80.8 YEARS), 3 PATIENTS UNDERWENT TRANSFEMORAL TAVI WITH THE MEDTRONIC EVOLUT R VALVE SYSTEM. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ONE DEATH OCCURRED DUE TO THROMBOEMBOLIC STROKE. THE AUTHORS DID NOT DISCLOSE THE BRAND NAME (MEDTRONIC, EDWARDS, BOSTON SCIENTIFIC, OR ABBOTT) OF THE VALVE USED TO TREAT THIS PATIENT; THEREFORE, A DIRECT CORRELATION WAS NOT MADE BETWEEN MEDTRONIC PRODUCT AND THE DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR PERMANENT PACEMAKER IMPLANTATION (8 CASES); NEW LEFT BUNDLE BRANCH BLOCK (12 C ASES); COMPLETE ATRIOVENTRICULAR BLOCK (5 CASES); NON-FATAL THROMBOEMBOLIC STROKE (1 CASE); TRANSIENT ISCHEMIC ATTACK (1 CASE); MILD TO MODERATE PARAVALVULAR LEAK (30 CASES); BLEEDING (4 CASES); AND ACCESS SITE VASCULAR COMPLICATION (4 CASES; NO INTERVENTIONS WERE REPORTED TO HAVE BEEN PERFORMED AS A RESULT). 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
    1032130 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

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