BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 6113883 · Received November 18, 2016

    Report

    Report Number
    2015691-2016-03424
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 31, 2016
    Report Date
    October 31, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: SYSTEM UPDATES PENDING. RESULTS: KNOWN INHERENT RISK OF PROCEDURE. PER THE INSTRUCTIONS FOR USE (IFU), HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION. PATIENTS UNDERGOING THE TAVR PROCEDURE CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. PATIENT RISK FACTORS FOR HYPOTENSION INCLUDE LOW EF, CAD, CHF, ARTERIOSCLEROSIS, HYPOVOLEMIA, AND ANEMIA. ADDITIONALLY, THESE PATIENTS ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE HYPOTENSION IS NOT UNCOMMON AND IS TREATED WITH STANDARD THERAPIES, INCLUDING VASOACTIVE DRUGS. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IN SOME CASES, THESE STANDARD MANEUVERS ARE NOT ADEQUATE, AND INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY IS REQUIRED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. AS A PRECAUTION, THE THV TRAINING MANUALS INSTRUCT THE OPERATOR TO MINIMIZE THE NUMBER AND DURATION OF RAPID BURST PACING EPISODES, AND ALLOW SUFFICIENT HEMODYNAMIC RECOVERY BEFORE INITIATING ANOTHER EPISODE OF RAPID PACING. IN THIS CASE, THE CAUSE OF THE LVOT OBSTRUCTION WAS LIKELY DUE TO THE PATIENT¿S PRE-EXISTING LARGE SEPTAL BULGE. THE CAUSE OF THE SUB SEQUENTIAL DEATH IS UNKNOWN, BUT MAY BE DUE TO PATIENT FACTORS (LOW EF) OR PROCEDURAL FACTORS (SEDATION MANAGEMENT) AS DESCRIBED ABOVE. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES.

    Description of Event or Problem · 1

    AS REPORTED BY OUR EDWARDS LIFESCIENCES AFFILIATE IN (B)(4), DURING A TRANSFEMORAL TAVR PROCEDURE, POST BALLOON AORTIC VALVULOPLASTY (BAV) WITH A NON-EDWARDS DEVICE, WIRE POSITION WAS LOST DURING THE BAV BALLOON REMOVAL. THE NATIVE VALVE HAD TO BE RE-CROSSED WITH SIGNIFICANT DIFFICULTY. THE WIRE POSITION IN THE LEFT VENTRICLE (LV) WAS NOT OPTIMAL DESPITE MULTIPLE ATTEMPTS TO RE-POSITION IT. THE LV CAVITY WAS NOTED TO BE ¿ABNORMALLY¿ SHAPED DUE A SEPTAL BULGE. A 23MM SAPIEN 3 VALVE AND COMMANDER DELIVERY SYSTEM WERE ADVANCED THROUGH THE ESHEATH AND VALVE ALIGNMENT WAS PERFORMED IN THE DESCENDING AORTA. THE NATIVE VALVE WAS CROSSED AND THE SAPIEN 3 VALVE WAS POSITIONED AT THE ANNULUS. AT THIS POINT, THE PATIENT BECAME VERY HYPOTENSIVE. THE DELIVERY SYSTEM AND VALVE WERE PULLER BACK INTO THE ASCENDING AORTA WHILE THE TAVI TEAM ATTEMPTED TO RESUSCITATE THE PATIENT. THE PATIENT WAS NOT ABLE TO BE RESUSCITATED AND EXPIRED DURING THE PROCEDURE. THE SAPIEN 3 VALVE WAS NEVER DEPLOYED. DURING THE POST CASE DISCUSSION, THE CAUSE OF DEATH WAS ATTRIBUTED TO TRANSIENT LVOT OBSTRUCTION FROM WHICH THE PATIENT WAS NOT ABLE TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766088 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23 60538652

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death| R