BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 3961542 · Received July 28, 2014

    Report

    Report Number
    2015691-2014-01708
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NON-FUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. DURING THE MANUFACTURING PROCESS, ALL EDWARDS VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE, THE EXACT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED WITH CERTAINTY; HOWEVER, SLOW RECOVERY OF BLOOD PRESSURE AND VENTRICULAR FUNCTION POST DEPLOYMENT MAY HAVE CONTRIBUTED TO THE EVENT. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AFTER DEPLOYMENT OF A 23MM SAPIEN VALVE IN A 70:30 AORTIC/VENTRICULAR POSITION, MODERATE CENTRAL AORTIC INSUFFICIENCY (CAI) WAS NOTED. IT APPEARED THAT THE NON CORONARY CUSP (NCC) LEAFLET WAS NOT FUNCTIONING. AT THAT POINT, THE SHEATH HAD ALREADY BEEN REMOVED FROM THE VENTRICLE AND THE VENTRICULOTOMY HAD BEEN SUTURED. THE VENTRICULOTOMY WAS REOPENED AND A SECOND VALVE WAS SUCCESSFULLY DEPLOYED EXACTLY INSIDE THE FIRST VALVE, RESOLVING THE AI. THE PATIENT WAS SUBSEQUENTLY REMOVED FROM CPB IN STABLE BUT CRITICAL CONDITION. AS REPORTED, AFTER THE FIRST VALVE WAS DEPLOYED THE AMOUNT OF AI THAT WAS PRESENT WAS NOT FULLY APPRECIATED. THE PATIENT'S PRESSURE REMAINED VERY LOW IN THE 30'S POST DEPLOYMENT AND THEY WERE PLACED ON CPB AND HAD MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION. AFTER SEVERAL MINUTES, THE VALVE FUNCTION WAS REASSESSED AND MODERATE CENTRAL AI WAS NOTED. AT THAT TIME, THE DECISION WAS MADE TO DEPLOY A SECOND VALVE. ACCORDING TO THE PHYSICIAN, THE PATIENT WASN'T ABLE TO BE WEANED FROM THE VENTILATOR AND MAY HAVE DEVELOPED HEPARIN-INDUCED THROMBOCYTOPENIA. THE PATIENT EXPIRED 14 DAYS POST PROCEDURE. PER POST PROCEDURE ECHO, THE SECOND VALVE WAS FUNCTIONING PROPERLY. THE NATIVE VALVE WAS NOT CALCIFIED AND THE AORTIC ROOT WAS MILDLY CALCIFIED. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM DURING DEPLOYMENT WAS REPORTED AS GOOD, AS WAS THE IMAGE INTENSIFIER ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438092 EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| R