BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 14569141 · Received June 1, 2022

    Report

    Report Number
    2025587-2022-01535
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 20, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE IS: PRODUCT ID: EVPROPLUS-29US, SERIAL #: (B)(4), UBD: 06-OCT-2023, UDI#: (B)(4). (B)(4). THE DEVICE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE MILD-MODERATE AORTIC INSUFFICIENCY WAS PARAVALVULAR LEAK (PVL). THE DAY OF THE IMPLANT PROCEDURE, COMPLETE HEART BLOCK (CHB) WAS NOTED, WHICH THE PERMANENT PACEMAKER WAS IMPLANTED FOR. 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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (D700279), AFTER THE VALVE WAS DEPL OYED, AN ECHOCARDIOGRAM REVEALED MILD-MODERATE AORTIC INSUFFICIENCY. THE PATIENT HAD SIGNIFICANT ANNULAR AND LEFT VENTRICULAR OUTFLOW TRACT CALCIUM THAT CONTRIBUTED TO THE AORTIC INSUFFICIENCY. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 24 MILLIMETER (MM) X 4 MM NON-MEDTRONIC BALLOON. AFTER THE BAV, AS THE BALLOON WAS REMOVED AND PASSING THE OUTFLOW PORTION OF THE VALVE FRAME, IT INTERACTED WITH ONE OF THE VALVE PADDLES. THE BALLOON PULLED THE VALVE FRAME ABOVE THE AORTIC ANNULUS AND ABOVE THE SINOTUBULAR JUNCTION. A SNARE WAS USED TO POSITION THE VALVE IN PLACE WHILE A SECOND VALVE (D698833) WAS LOADED ONTO A NEW DELIVERY CATHETER SYSTEM (DCS). THE DCS ADVANCED THROUGH THE FIRST VALVE FOR A SUCCESSFUL VALVE IMPLANT. ONE DAY POST-OPERATIVE OF THE VALVE IMPLANT, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323867 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-29US 00763000211127

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention