BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM, 26MM

    MDR report key: 5593368 · Received April 20, 2016

    Report

    Report Number
    2015691-2016-01310
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 29, 2016
    Report Date
    March 29, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. IN THIS CASE, THE EXACT CAUSE OF THE VESSEL PERFORATION CANNOT BE DETERMINED; HOWEVER, THE ABDOMINAL AORTIC PERFORATION MAY HAVE BEEN CAUSED BY THE GUIDEWIRE AND/OR DELIVERY SYSTEM DURING INSERTION OF THE DEVICE FOR VALVE DEPLOYMENT. 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 FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT DIED AFTER COMPLICATIONS FROM AN ABDOMINAL AORTA PERFORATION DURING A TRANSFEMORAL PROCEDURE. AS REPORTED, A BALLOON VALVULOPLASTY (BAV) WAS PERFORMED AND AORTIC INSUFFICIENCY (AI) WAS NOTED BY TEE. THE DELIVERY SYSTEM WAS INSERTED AND WAS ADVANCED THROUGH THE SHEATH. UPON EXITING THE SHEATH THE DELIVERY SYSTEM "KNUCKLED" ON ITS SELF INTO THE WALL OF THE AORTA. THE PATIENT'S PRESSURE DROPPED (APPROXIMATELY 45MMHG), A DECISION WAS MADE TO DEPLOY THE VALVE. THE PATIENT'S PRESSURE REMAINED LOW AND DEPLOYMENT OF THE VALVE WAS COMPLETED. AN ATTEMPT TO INCREASE BLOOD PRESSURE VIA PHARMACOLOGICAL INTERVENTION WAS INITIATED. THE PRESSURE WAS NOT INCREASING, CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED; VENTRICULAR FIBRILLATION WAS NOTED AND DEFIBRILLATION WAS ATTEMPTED MULTIPLE TIMES. A TEE DEMONSTRATED SEVERELY COMPROMISED LV FUNCTION. THE PATIENT WAS PLACED ON ECMO AND BYPASS. MULTIPLE IMAGES WERE OBTAINED AND THE ABDOMINAL AORTOGRAPHY DEMONSTRATED A PERFORATION AND HEMATOMA. PER REPORT, THE BALLOON WAS NOT THE CAUSE FOR THE AI BUT THE PERFORATION OF THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248197 EDWARDS COMMANDER DELIVERY SYSTEM, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS26

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death