BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 16775372 · Received April 20, 2023

    Report

    Report Number
    2025587-2023-01592
    Event Type
    Death
    Date Received
    April 20, 2023
    Date of Event
    February 3, 2023
    Report Date
    June 14, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: 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. 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.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B2 - OUTCOME ATTRIBUTED TO ADVERSE EVENT AND DATE OF DEATH B5 - SECOND PARAGRAPH H1 - TYPE OF REPORTABLE EVENT H6 - DEVICE CODE ADDITIONAL CODES - IMF CODE. 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 FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS NOTED THE COMPLETE ATRIO -VENTRICULAR BLOCK DID NOT IMPROVE. SUBSEQUENTLY, ONE DAY POST-IMPLANT, A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS NOTED THE COMPLETE ATRIO -VENTRICULAR BLOCK DID NOT IMPROVE. SUBSEQUENTLY, ONE DAY POST-IMPLANT, A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING THE 1 YEAR AND 3 MONTHS FOLLOWING THE VALVE IMPLANT, THE PATIENT'S FAMILY REPORTED THAT THE PATIENT HAD DIED AND THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746215 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-29US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R