BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 11871165 · Received May 24, 2021

    Report

    Report Number
    2025587-2021-01651
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 24, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LONG-TERM CLINICAL OUTCOMES AND CAROTID ULTRASOUND FOLLOW-UP OF TRANSCAROTID TAVI. PROSPECTIVE SINGLE-CENTER REGISTRY ARTICLE TITLE. JOURNAL OF CLINICAL MEDICINE. 2021; 10:1499. DOI: 10.3390/JCM10071499. 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 VIA LITERATURE REGARDING LONG-TERM CLINICAL OUTCOMES AND CAROTID ULTRASOUND FOLLOW-UP AFTER TRANSCAROTID TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2017 AND 2019. THE STUDY POPULATION INCLUDED 33 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 77 YEARS), 24 OF WHOM WERE IMPLANTED WITH MEDTRONIC EVOLUTR TAV. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS, ONE INTRAOPERATIVE DEATH OCCURRED DUE TO AN ANNULAR RUPTURE PRIOR TO PROSTHESIS IMPLANTATION. ANOTHER DEATH DUE TO AN UNKNOWN CAUSE OCCURRED AFTER DISCHARGE. NO DEATHS WERE ASSOCIATED WITH A MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW-ONSET ATRIAL FIBRILLATION (AFIB), MYOCARDIAL INFARCTION (MI), CARDIAC TAMPONADE, PERMANENT PACEMAKER IMPLANT, TRANSIENT ISCHEMIC ATTACK (TIA) AND STROKE. BASED ON THE AVAILABLE INFORMATION, A 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
    767182 EVOLUT R TRANSCATHETER AORTIC VALVE NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention