BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO+ SYSTEM

    MDR report key: 10975494 · Received December 9, 2020

    Report

    Report Number
    10975494
    Event Type
    Death
    Date Received
    December 9, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MEDTRONIC COREVALVE LLC
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ELDERLY FEMALE WITH SEVERE AORTIC STENOSIS WAS BROUGHT TO THE CATH LAB FOR A TAVR PROCEDURE. GENERAL ANESTHESIA WAS INITIATED. TEE PROBE WAS INTRODUCED. HEMODYNAMIC MONITORING WAS PERFORMED THROUGHOUT THE CASE. LEFT FEMORAL ARTERIAL ACCESS AND RIGHT FEMORAL ARTERIAL AND VENOUS ACCESS WERE OBTAINED BY MODIFIED SELDINGER TECHNIQUE A TTE PROBE AND TEMPORARY TRANSVENOUS PACEMAKER WERE PLACED IN THE RIGHT VENTRICLE BY RIGHT FEMORAL VEIN. 6 FR PIGTAIL CATHETER WAS ADVANCED FROM RIGHT FEMORAL ARTERY TO THE ASCENDING AORTA. ASCENDING AORTOGRAPHY WAS PERFORMED TO ESTABLISH OPTIMAL VALVE DEPLOYMENT ANGLE. 14 FRENCH SHEATH WAS THEN PLACED BY THE LEFT FEMORAL ARTERY OVER LUNDERQUIST WIRE. 6 FRENCH AL1 CATHETER WAS THEN ADVANCED IN THE ASCENDING AORTA OVER 0.035 J TIPPED WIRE. AORTIC VALVE WAS THEN CROSSED WITH A STRAIGHT 0.035 WIRE AND AL1 CATHETER WAS ADVANCE IN THE LEFT VENTRICLE OVER THE WIRE. STRAIGHT WIRE EXCHANGED TO A REGULAR J-TIPPED WIRE INTO THE VENTRICLE OVER A PIGTAIL CATHETER. CONFIDA WIRE WAS THEN ADVANCED TO THE APEX OF LEFT VENTRICLE THROUGH THE PIGTAIL CATHETER. PIGTAIL CATHETER WAS THEN REMOVED. MEDTRONIC COREVALVE EVOLUT PRO SIZE 26 VALVE WAS THEN ADVANCED OVER THE CONFIDA WIRE TO THE ASCENDING AORTA. THE AORTIC VALVE WAS THEN CROSSED WITH THE EVOLUT PRO VALVE. DEPLOYMENT POSITION WAS CONFIRMED WITH ASCENDING AORTOGRAPHY. AT THIS STAGE, PATIENT BECAME SEVERELY HYPOTENSIVE. CORE VALVE WAS BROUGHT BACK TO THE DESCENDING AORTA UNDEPLOYED AND REMOVED. PRESSURE FURTHER DROPPED DESPITE ADMINISTRATING VASOPRESSORS. THERE WAS NO PALPABLE PULSE. CPR WAS INITIATED. DC SHOCK WAS DELIVERED FEW TIME FOR V FIB. TEE IMAGES SHOWED NO AI BUT AKINESIA OF ENTIRE LV. WITH THE PIGTAIL CATHETER, ABDOMINAL AORTOGRAM WAS THEN PERFORMED THAT SHOWED PERFORATION OF ABDOMINAL AORTA. A 10 X 40 MM BALLOON WAS THEN INFLATED IN THE AORTA PROXIMAL TO THE PERFORATION TO REDUCE DISTAL FLOW. CPR WAS CONTINUED WITH NO SUCCESS AND THE PATIENT DIED. TWO MEDTRONIC SALES REPRESENTATIVES WERE PRESENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444341 EVOLUT PRO+ SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Death