BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 19028433 · Received April 2, 2024

    Report

    Report Number
    2025587-2024-02059
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    January 4, 2024
    Report Date
    April 2, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HABIB JABAGI, RICHARD E. SHAW, LARA GHARIBEH, RAJIV TAYAL, HUSSEIN RAHIM, FRANCIS KIM, ALEX ZAPOLANSKI, JUAN B. GRAU. PATIENT CHARACTERISTICS AND OUTCOMES ASSOCIATED WITH SENTINEL PROTECTION DEVICE USE IN PATIENTS WITH AORTIC VALVE DISEASE UNDERGOING TAVR IN A ¿REAL-WORLD¿ SETTING. REV. CARDIOVASC. MED. 2024, 25(1), 3. HTTPS://DOI.ORG/10.31083/J.RCM2501003 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), AND EVOLUT PRO PLUS (PRODUCT CODE NPT, PMA# P130021). 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE USE OF THE SENTINEL CEREBRAL PROTECTION SYSTEM IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). MEDTRONIC (EVOLUT, EVOLUT PRO, OR EVOLUT PRO PLUS = 113) AND NON-MEDTRONIC (SAPIEN 3 OR S3 ULTRA = 129) VALVE TYPES WERE USED IN THE STUDY. THE AUTHORS OBSERVED THREE IN-HOSPITAL DEATHS. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER ADVERSE OUTCOMES INCLUDED: STROKE/CEREBROVASCULAR ACCIDENT (CVA), BLEEDING/VASCULAR EVENTS, AND RED BLOOD CELL TRANSFUSIONS. AS STATED IN THE ARTICLE, THE AUTHORS ONLY INCLUDED CVA EVENTS IN THE STUDY DATA THAT MET THE CRITERIA FOR ¿PERMANENT STROKE¿ (DEFINED AS ANY CONFIRMED NEUROLOGIC DEFICIT OF ABRUPT ONSET CAUSED BY A DISTURBANCE IN CEREBRAL BLOOD SUPPLY WITH DURATION = 24 HOURS). NO ADDITIONAL ADVERSE OUTCOMES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729077 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| L