BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9925064 · Received April 3, 2020

    Report

    Report Number
    2025587-2020-01127
    Event Type
    Injury
    Date Received
    April 3, 2020
    Date of Event
    March 16, 2020
    Report Date
    April 3, 2020
    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: BUDZIANOWSKI J ET AL. MECHANICAL THROMBECTOMY FOR ACUTE ISCHEMIC STROKE AFTER IMPLANTATION OF COREVALVE EVOLUT R IN A DEGENERATIVE BIOPROSTHETIC SURGICAL VALVE. KARDIOL POL. 2020 MAR 16. DOI: 10.33963/KP.15234. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE . 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 A LITERATURE CASE REPORT REGARDING A (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF CORONARY ARTERY BYPASS GRAFTING, INFECTIVE ENDOCARDITIS, REDUCED LEFT VENTRICULAR EJECTION FRACTION, AND SURGICAL AORTIC VALVE REPLACEMENT. THE PATIENT PRESENTED WITH SEVERE DEGENERATION OF A 25 MM NON-MEDTRONIC SURGICAL VALVE. ANGIOGRAPHY SHOWED MASSIVE ATHEROSCLEROTIC PLAQUES ALONG THE AORTIC ARCH AND ITS BRANCHES. THE PATIENT UNDERWENT TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION WITH A 29 MM MEDTRONIC EVOLUT R TRANSCATHETER VALVE (SERIAL NUMBER NOT PROVIDED). CONTROL ANGIOGRAPHY AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY VERIFIED PROPER VALVE POSITION. AFTER AWAKENING FROM ANESTHESIA, THE PATIENT EXHIBITED SYMPTOMS OF A LEFT-HEMISPHERIC STROKE WITH RIGHT-SIDED HEMIPARESIS AND APHASIA. CEREBROVASCULAR ANGIOGRAPHY REVEALED A NEW OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY. SUBSEQUENTLY, A MECHANICAL THROMBECTOMY WAS PERFORMED. FOLLOWING THE THROMBECTOMY, THE PATIENT¿S CONDITION IMPROVED. ONE DAY LATER, A NON-CONTRAST HEAD COMPUTED TOMOGRAPHY SCAN SHOWED A DIFFUSED, HYPODENSE ZONE OF THE LEFT TEMPORAL LOBE, INSULA AND THE LEFT LATERAL SULCUS. IT WAS NOTED THAT THE RIGHT-SIDED PARALYSIS REDUCED SIGNIFICANTLY PRIOR TO HOSPITAL DISCHARGE. THREE MONTHS LATER, AN ECHOCARDIOGRAM OBSERVED A PEAK TRANSVALVULAR GRADIENT OF 30 MMHG. NO TREATMENT OR INTERVENTION WAS REPORTED AS A RESULT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388355 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention| S