BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 17922776 · Received October 12, 2023

    Report

    Report Number
    2025587-2023-04110
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FUJII M, YAMAMOTO H, TAKAHASHI N, MASUMOTO A, TSUKIYAMA Y, TAKAYA T. BILATERAL DELAYED CORONARY OBSTRUCTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A SELF-EXPANDABLE BIOPROSTHETIC VALVE. JACC CARDIOVASC INTERV. 2023;16(16):2043-2046. DOI:10.101 6/J.JCIN.2023.06.009 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A PATIENT WHO UNDERWENT SUCCESSFUL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A MEDTRONIC 26 MM EVOLUT PRO+ VALVE. FIVE DAYS AFTER TAVR, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED NO ABNORMALITIES. THREE MONTHS LATER,THE PATIENT PRESENTED WITH PERSISTENT CHEST PAIN. EMERGENCY CORONARY ANGIOGRAPHY (CAG) REVEALED AN OSTIAL RIGHT CORONARY ARTERY STENOSIS. SUBSEQUENTLY, PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH ¿ORTHOTOPIC¿ STENTING (STENT IMPLANTATION THROUGH THE CELLS OF THE EVOLUT PRO+ FRAME INTO THE CORONARY ARTERY) WAS PERFORMED. DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND PRASUGREL WAS ALSO ADDED TO THE PATIENT¿S ORAL ANTICOAGULANT REGIMEN. FIVE DAYS LATER, THE PATIENT PRESENTED WITH RECURRENT PERSISTENT CHEST PAIN, THIS TIME WITH CARDIOGENIC SHOCK. EMERGENCY CAG SHOWED PROGRESSIVE STENOSIS IN THE OSTIAL LEFT MAIN CORONARY ARTERY. INTRAVASCULAR ULTRASOUND REVEALED FOCAL STENOSIS WITH CIRCUMFERENTIAL LOW-ATTENUATION SIGNALS AT THE ENTRANCE TO THE EVOLUT PRO+ STRUTS, SUGGESTING SOFT TISSUE COMPATIBLE WITH THROMBUS. THE AUTHORS PERFORMED PCI WITH ORTHOTOPIC STENTING, WHICH IMPROVED THE LEFT CORONARY FLOW. AFTERWARD, CTA SHOWED HYPOATTENUATED TISSUES AROUND THE EVOLUT PRO+ STRUTS, BUT NO LARGE THROMBUS WITHIN THE NARROW SINUSES OF VALSALVA (SOVS). THE AUTHORS CONCLUDED, ¿THE BILATERAL CORONARY OBSTRUCTION MAY BE FROM THE NARROW SOVS SURROUNDED BY A SEALED SINOTUBULAR JUNCTION AND TAVR VALVE SKIRT.¿ IT WAS NOTED THAT NO FURTHER CARDIOVASCULAR EVENTS OCCURRED DURING THE SUBSEQUENT YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311543 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-26

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H| L