BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10134901 · Received June 9, 2020

    Report

    Report Number
    2025587-2020-01835
    Event Type
    Death
    Date Received
    June 9, 2020
    Date of Event
    May 11, 2020
    Report Date
    September 4, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. WITHOUT THE SERIAL NUMBER FOR THIS DEVICE A DEVICE HISTORY REVIEW WAS UNABLE TO BE PERFORMED. PARAVALVULAR LEAK (PVL) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. NO MITIGATING TREATMENTS OR PROCEDURES WERE REQUIRED BY PHYSICIAN TO ADDRESS THE ISSUE, AND IT WAS HENCE REPORTED THAT THE PVL REDUCED TO MILD ONE DAY FOLLOWING THE IMPLANT. THE REPORT OF DEATH AT NINE DAYS POST-IMPLANT WAS ASCERTAINED TO BE CARDIOVASCULAR; HOWEVER, IT IS UNKNOWN IF THE DEVICE OR PROCEDURE CONTRIBUTED TO THE PATIENT DEATH. DETAILED INFORMATION ABOUT THE EVENT WAS NOT AVAILABLE AND IT IS UNKNOWN IF AN AUTOPSY OR AN EXPLANT OF THE VALVE WAS PERFORMED. WITH THE LIMITED INFORMATION AVAILABLE, NO CONCLUSIVE ASSESSMENT COULD BE MADE REGARDING THE RELATIONSHIP OF THE DEVICE TO THE PATIENT DEATH. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALFUNCTION. TRENDS FOR THIS EVENT TYPE HAVE BEEN ASSESSED AND HAVE BEEN REVIEWED IN THE PRODUCT QUALITY MEETING (PQM) PER AND NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. 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 · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, SEVERE PARAVALVULAR LEAK (PVL) WAS REPORTED. ONE DAY FOLLOWING THE IMPLANT THE PVL HAD REDUCED TO MILD. NINE DAYS FOLLOWING THE VALVE IMPLANT THE PATIENT WAS REPORTED TO HAVE DIED DUE TO CARDIOVASCULAR CAUSES. THERE WAS NO REPORTED RELATIONSHIP BETWEEN THE DEATH AND THE PROCEDURE. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599935 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death