BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 21490283 · Received February 28, 2025

    Report

    Report Number
    2025587-2025-01538
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 3, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ZENDJEBIL S, AKODAD M, IUNG B, ET AL. CORONARY EVENTS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: INSIGHTS FROM THE FRANCE TAVI REGISTRY. JACC CARDIOVASC INTERV. 2025;18(2):229-243. DOI: 10.1016/J.JCIN.2024.09.005 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC TRANSCATHETER VALVE BRANDS USED IN THE STUDY: COREVALVE (PRODUCT CODE NPT, PMA#: P130021), EVOLUT R (PRODUCT CODE NPT, PMA#: P130021), AND EVOLUT PRO (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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - SECOND PARAGRAPH. 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 INCIDENCE AND IMPACT OF CORONARY EVENTS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 64,660 PATIENTS WHO UNDERWENT TAVR WITH EITHER A NON-MEDTRONIC BALLOON-EXPANDABLE VALVE (BEV = 41,266) OR A MEDTRONIC SELF-EXPANDING VALVE (SEV = 23,394). IN THE SEV GROUP, THE AUTHORS OBSERVED DEATHS BEFORE DISCHARGE AFTER TAVR AND OBSERVED ADDITIONAL DEATHS FOLLOWING A FIRST CORONARY EVENT AFTER TAVR DISCHARGE (DEFINED AS REHOSPITALIZATION FOR STABLE ANGINA OR ACUTE CORONARY SYNDROME). NONE OF THE DEATHS WERE RECOUNTED IN DETAIL. OTHER ADVERSE EVENTS THAT OCCURRED IN THE SEV GROUP: MORE THAN ONE VALVE IMPLANTED; AORTIC REGURGITATION (MODERATE TO SEVERE); CORONARY OCCLUSION; ACUTE CORONARY SYNDROME; CORONARY EVENT NECESSITATING CORONARY ANGIOGRAPHY, PERCUTANEOUS CORONARY INTERVENTION, OR CORONARY ARTERY BYPASS GRAFTING; VALVE EMBOLIZATION; ANNULUS RUPTURE; AORTIC DISSECTION; TAMPONADE; NEED FOR PERMANENT PACEMAKER IMPLANT; URGENT SURGICAL AORTIC VALVE REPLACEMENT; CARDIAC SURGERY; STROKE; NEED FOR TRANSFUSION; ENDOCARDITIS; ACUTE KIDNEY INJURY/KIDNEY FAILURE; AND REHOSPITALIZATION FOR HEART FAILURE.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE INCIDENCE AND IMPACT OF CORONARY EVENTS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 64,660 PATIENTS WHO UNDERWENT TAVR WITH EITHER A NON-MEDTRONIC BALLOON-EXPANDABLE VALVE (BEV = 41,266) OR A MEDTRONIC SELF-EXPANDING VALVE (SEV = 23,394). IN THE SEV GROUP, THE AUTHORS OBSERVED DEATHS BEFORE DISCHARGE AFTER TAVR AND OBSERVED ADDITIONAL DEATHS FOLLOWING A FIRST CORONARY EVENT AFTER TAVR DISCHARGE (DEFINED AS REHOSPITALIZATION FOR STABLE ANGINA OR ACUTE CORONARY SYNDROME). NONE OF THE DEATHS WERE RECOUNTED IN DETAIL. OTHER ADVERSE EVENTS THAT OCCURRED IN THE SEV GROUP: MORE THAN ONE VALVE IMPLANTED; AORTIC REGURGITATION (MODERATE TO SEVERE); CORONARY OCCLUSION; ACUTE CORONARY SYNDROME; CORONARY EVENT NECESSITATING CORONARY ANGIOGRAPHY, PERCUTANEOUS CORONARY INTERVENTION, OR CORONARY ARTERY BYPASS GRAFTING; VALVE EMBOLIZATION; ANNULUS RUPTURE; AORTIC DISSECTION; TAMPONADE; NEED FOR PERMANENT PACEMAKER IMPLANT; URGENT SURGICAL AORTIC VALVE REPLACEMENT; CARDIAC SURGERY; STROKE; NEED FOR TRANSFUSION; ENDOCARDITIS; ACUTE KIDNEY INJURY/KIDNEY FAILURE; AND REHOSPITALIZATION FOR HEART FAILURE. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS (DEATHS AND NON-DEATH OUTCOMES) OBSERVED DURING THE STUDY. HOWEVER, NO EVIDENCE WAS PROVIDED TO CORROBORATE THIS STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123410 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death