BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 21158898 · Received January 15, 2025

    Report

    Report Number
    2025587-2025-00379
    Event Type
    Death
    Date Received
    January 15, 2025
    Date of Event
    November 11, 2024
    Report Date
    January 15, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AMAT-SANTOS IJ, GARCÍA-GÓMEZ M, AVANZAS P, ET AL. SURGICAL VS TRANSCATHETER TREATMENT IN PATIENTS WITH CORONARY ARTERY DISEASE AND SEVERE AORTIC STENOSIS. JACC CARDIOVASC INTERV. 2024;17(21):2472-2485. DOI:10.1016/J.JCIN.2024.09.003 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC TAVR PRODUCT REFERENCED IN THE ARTICLE: ¿EVOLUT¿. BASED ON THE TIMEFRAME OF THE STUDY (2018 ¿ 2022), THE EVOLUT R, EVOLUT PRO, AND EVOLUT PRO+ ITERATIONS OF THE EVOLUT PRODUCT FAMILY MAY HAVE BEEN USED. 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 PATIENT OUTCOMES OF CONCOMITANT TRANSCATHETER AORTIC VALVE REPLACEMENT AND PERCUTANEOUS CORONARY INTERVENTION (TAVR + PCI) COMPARED TO COMBINED SURGICAL AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFTING (SAVR + CABG). THE MANUFACTURERS AND/OR BRAND NAMES OF THE DEVICES USED IN THE SAVR + CABG GROUP (N = 713) WERE NOT DISCLOSED; THEREFORE, THE REMAINDER OF THIS SUMMARY ONLY PERTAINS TO THE OUTCOMES THAT OCCURRED IN THE TAVR + PCI GROUP (N = 625). MEDTRONIC EVOLUT (N = 195) AND VARIOUS NON-MEDTRONIC (N = 430) VALVE TYPES WERE IMPLANTED IN THE PATIENT POPULATION. THE AUTHORS OBSERVED 5 PROCEDURAL DEATHS, 21 IN-HOSPITAL DEATHS WITH STROKE, AND A TOTAL OF 56 DEATHS WITH STROKE AT ONE-YEAR POST-PROCEDURE. OTHER ADVERSE OUTCOMES INCLUDED: VALVE EMBOLIZATION; CORONARY OCCLUSION; ANNULAR RUPTURE; TAMPONADE; REINTERVENTION; NEW PERMANENT PACEMAKER IMPLANTATION; NEW ONSET ATRIAL FIBRILLATION; MAJOR BLEEDING; MAJOR VASCULAR COMPLICATIONS; STROKE; TRANSIENT ISCHEMIC ATTACK; MYOCARDIAL INFARCTION; AORTIC REGURGITATION (MILD, MODERATE, OR SEVERE); HEART FAILURE; PROSTHESIS-PATIENT MISMATCH; NEED FOR REHOSPITALIZATION; NEED FOR NEW REVASCULARIZATION; AND ACUTE KIDNEY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364464 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death