BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 13290318 · Received January 19, 2022

    Report

    Report Number
    2025587-2022-00136
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 24, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000211127
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING THE DISLODGE, MODERATE CENTRAL AORTIC REGURGITATION WAS OBSERVED. NO A DDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPDATED: B5, H6 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

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE COMPUTED TOMOGRAPHY (CT) MEASUREMENTS INDICATED THIS PATIENT WAS SIZED FOR A 29 MM VALVE. IT WAS REPORTED THAT THE NATIVE VALVE WAS HEAVILY CALCIFIED, INCLUDING ANNULAR CALCIFICATION NEAR THE NON-CORONARY CUSP (NCC) EXTENDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE NATIVE ANNULUS WAS PRE-DILATED USING A 20 MM BALLOON AORTIC VALVULOPLASTY (BAV). AT 80% DEPLOYED, THE VALVE WAS REPORTED TO BE AT A DEPTH OF 2-3 MM ON THE NCC AND 2-3 MM ON THE LEFT CORONARY CUSP (LCC). UPON RELEASE, THE VALVE MOVED SLIGHTLY UP. AFTER MIRRORING THE DELIVERY CATHETER SYSTEM (DCS), IT WAS EVIDENT THAT THE VALVE HAD DISLODGE UP AND OUT OF THE BASAL PLANE, RESULTING IN MODERATE AORTIC INSUFFICIENCY (AI). A SECOND TRANSCATHETER VALVE ((B)(4)) WAS SUCCESSFULLY IMPLANTED IN A DEEPER POSITION. THE PATIENT WAS REPORTED TO BE STABLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888984 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-29US 00763000211127

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention