BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6138639 · Received December 1, 2016

    Report

    Report Number
    2025587-2016-01892
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    November 10, 2016
    Report Date
    May 26, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169638006
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. IN THIS EVENT, IT WAS MOST LIKELY DUE TO INACCURATE POSITIONING AS IT WAS REPORTED THAT THE VALVE WAS RECAPTURED. AS THE VALVE WAS BEING RECAPTURED, THE PATIENT¿S PRESSURE DROPPED. THE VALVE WAS DEPLOYED AND WAS FUNCTIONING PROPERLY BUT THE PATIENT¿S PRESSURE WAS UNABLE TO RECOVER. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE EVOLUTR INSTRUCTIONS FOR USE (IFU). IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. THE PATIENT EXPIRED DURING THE PROCEDURE. NEITHER AUTOPSY NOR EXPLANT WERE PERFORMED. WITH THE LIMITED INFORMATION AVAILABLE, A RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH COULD NOT BE ESTABLISHED. NO ALLEGATIONS WERE MADE RELATING THE VALVE OR ITS FUNCTION TO THE DEATH. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALFUNCTION. 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 THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS DEPLOYED ONCE BUT WAS RECAPTURED DUE TO MODERATE PARAVALVULAR LEAK (PVL). DURING RECAPTURE, THE PATIENT¿S PRESSURE DROPPED. THE VALVE WAS DEPLOYED IN AN ATTEMPT TO STABILIZE AND APPEARED TO BE FUNCTIONING PROPERLY, HOWEVER THE PATIENT'S PRESSURE NEVER RECOVERED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR APPROXIMATELY 45 MINUTES AND THE PATIENT WAS SHOCKED NUMEROUS TIMES DUE TO BEING IN ATRIAL FIBRILLATION (AFIB). THE PATIENT SUBSEQUENTLY EXPIRED DURING THE PROCEDURE. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788810 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29-US 00643169638006

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death