BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 20087847 · Received August 28, 2024

    Report

    Report Number
    2025587-2024-04854
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 28, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: DREGER ET AL. TAVR-IN-TAVR IN A PATIENT WITH A 12-YEAR-OLD CHIMNEY STENT: THE INVERTED CULOTTE DOUBLE CHIMNEY TECHNIQUE. JACC CARDIOVASC INTERV. 2024 AUG 12;17(15):1846-1848. DOI: 10.1016/J.JCIN.2024.05.037. EPUB 2024 JUL 17. EARLIEST DATE OF PUBLICATION 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. 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 A 76-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF BYPASS SURGERY 22 YEARS PRIOR TO TREAT ISCHEMIC CARDIOMYOPATHY AND TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) 12 YEARS PRIOR TO TREAT SEVERE AORTIC STENOSIS. DURING THE TAVR IMPLANT PROCEDURE, A MEDTRONIC 29-MM COREVALVE BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED; HOWEVER, DURING THE PROCEDURE THE PATIENT EXPERIENCED ACUTE OBSTRUCTION OF THE LEFT CORONARY ARTERY WHICH REQUIRED EMERGENCY IMPLANTATION OF A ¿CHIMNEY¿ STENT FROM THE LEFT MAIN INTO THE LEFT CORONARY SINUS. MORE RECENTLY, THE PATIENT PRESENTED WITH SEVERE AORTIC STENOSIS WITH A MEAN GRADIENT OF 29 MMHG DUE TO STRUCTURAL BIOPROSTHETIC VALVE DEGENERATION. CORONARY ANGIOGRAPHY SHOWED A PROXIMALLY OCCLUDED LEFT ANTERIOR DESCENDING ARTERY, CHRONIC TOTAL OCCLUSION OF THE TWO VEIN GRAFTS AND THE RIGHT CORONARY ARTERY, AND COLLATERAL CHANNELS FROM THE LEFT CIRCUMFLEX ARTERY TO THE RIGHT CORONARY ARTERY. COMPUTED TOMOGRAPHY REVEALED SEVERE COMMISSURAL MISALIGNMENT OF THE COREVALVE. GIVEN THE PATIENT¿S HIGH SURGICAL RISK THE HEART TEAM CHOSE A TAVR-IN-TAVR PROCEDURE. A NON-MEDTRONIC 26-MM BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED INSIDE THE COREVALVE, AND A SECOND ¿CHIMNEY¿ STENT WAS PLACED TO PREVENT CORONARY OBSTRUCTION. IMAGING CONFIRMED SATISFACTORY EXPANSION OF BOTH ¿CHIMNEY¿ STENTS AND PRESERVED PERFUSION OF THE LEFT CORONARY ARTERY. POST-PROCEDURAL ECHOCARDIOGRAPHY SHOWED GOOD FUNCTION OF THE NEW BIOPROSTHETIC VALVE WITH A MEAN GRADIENT OF 6 MMHG. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573624 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention| H| L