BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 18539612 · Received January 18, 2024

    Report

    Report Number
    2025587-2024-00267
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 17, 2024
    Report Date
    April 15, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID D-EVPROP23-29 (LOT: 0011846923); PRODUCT TYPE: 0195-HEART VALVES. PRODUCT ID L-EVPROP23-29 (LOT: 0011908611); PRODUCT TYPE: 0195-HEART VALVES. PRODUCT ID EVPROPLUS-29 (J084952); PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID UNKNOWN MANUFACTURER BALLOON; PRODUCT TYPE: VALVULOPLASTY BALLOON; PRODUCT ID D-EVPROP23-29; PRODUCT TYPE: 0195-HEART VALVES; PRODUCT ID L-EVPROP23-29; PRODUCT TYPE: 0195-HEART VALVES; SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. THE EVENT FOR DEVICE J084952 PERTAINING TO THE FIRST VALVE (INFOLD) WAS REPORTED IN REGULATORY REPORT NUMBER 2025587-2024-00265. 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.

    Additional Manufacturer Narrative · 0

    UPDATED: B5. 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.

    Additional Manufacturer Narrative · 0

    UPDATED H.6 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (J084952), THE VALVE WAS LOADED ONTO THE DELIVERY CATHETER SYSTEM (DCS) AND FLUOROSCOPY INSPECTION REVEALED A CROWN OVERLAP WAS PRESENT NOT FURTHER THAN THE FOURTH NODE. THE VALVE WAS IMPLANTED WITHOUT PERFORMING A PRE-BALLOON AORTIC VALVULOPLASTY (BAV). AT 80% DEPLOYMENT, AN INFOLD WAS NOTED. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW VALVE (J098889) WAS LOADED AND FLUOROSCOPY INSPECTION REVEALED A CROWN OVERLAP WAS PRESENT TO THE 3RD NODE. A PRE-BAV WAS PERFORMED WITH A 20 MILLIMETER (MM) BALLOON. THE VALVE WAS DEPLOYED. IT WAS NOTED THAT THERE WAS UNDER EXPANSION OF THE VALVE. THE VALVE WAS CONTINUED TO BE DEPLOYED UNTIL 80% AND THE EXPANSION WAS CHECKED IN THE LEFT ANTERIOR OBLIQUE (LAO) AND RIGHT ANTERIOR OBLIQUE (RAO). IT WAS DETERMINED TO PLACE THE VALVE. A POST BAV WAS PERFORMED WITH A 24 MILLIMETER (MM) BALLOON WITH GOOD RESULT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A PROCEDURAL DELAY OCCURRED AS A RESULT OF THE INFOLD BECAUSE IT NECESSITATED LOADING A NEW VALVE. ACCORDING TO THE PHYSICIAN, LOADING AND CALCIUM IN THE PATIENT'S ANATOMY MAY HAVE CONTRIBUTED TO THE INFOLD. IT WAS REPORTED THAT THE SECOND VALVE WAS STILL UNDER-EXPANDED WHEN CHECKED AT 80% DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774285 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-29

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown