BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2993321 · Received March 7, 2013

    Report

    Report Number
    2015691-2013-19482
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE AFFECTED SAPIEN VALVE SHOWS THE DEVICE MET SPECIFICATIONS PRIOR TO DISTRIBUTION OF DEVICE. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, AORTIC INSUFFICIENCY IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DEPLOYMENT OF THE SAPIEN VALVE TOO AORTIC HAS THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, THE EXACT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. PER THE INFORMATION RECEIVED, THE VALVE WAS DEPLOYED AS RECOMMENDED. IT IS POSSIBLE A COMBINATION OF PATIENT (I.E. SEVERELY CALCIFIED NATIVE VALVE/LEAFLET AND AORTIC ROOT) AND UNKNOWN PROCEDURAL FACTORS CAUSED OR CONTRIBUTED TO THIS EVENT. ADDITIONAL INFORMATION FOR THIS CASE HAS BEEN REQUESTED, HOWEVER TO DATE, IT HAS NOT BEEN RECEIVED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DEATH WAS PROVIDED IN THE INTIAL REPORT, THE DEATH WAS NON-CARDIAC THUS WAS NOT ATTRIBUTED TO THE EDWARDS DEVICE.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE IMPLANT PATIENT REGISTRY, DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE PATIENT RECEIVED TWO 26MM SAPIEN TRANSCATHETER HEART VALVES. PER ADDITIONAL INFORMATION RECEIVED FROM THE EDWARDS CLINICAL SPECIALIST, THIS WAS A TRANSAPICAL CASE. THE SECOND VALVE WAS IMPLANTED FOR SEVERE AORTIC INSUFFICIENCY THAT WAS ATTRIBUTED TO ONE OF THE VALVE LEAFLETS ON THE FIRST SAPIEN VALVE NOT FUNCTIONING, WHICH WAS CONFIRMED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE IMPLANTING PHYSICIAN DID NOT KNOW THE REASON FOR THE NON-FUNCTIONING LEAFLET AND INDICATED THE DEPLOYMENT OF THE VALVE DID NOT APPEAR TO BE TOO AORTIC. DURING THIS CASE, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT. THERE WAS ADEQUATE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE. THE IMAGE INTENSIFIER ANGLE WAS DESCRIBED AS GOOD. THERE WAS MODERATE MITRAL ANNULAR CALCIFICATION AND NO VENTRICULAR SEPTAL HYPERTROPHY. THE PATIENT'S NATIVE VALVE/ LEAFLET AND AORTIC ROOT CALCIFICATION WAS DESCRIBED AS SEVERE. THE PATIENT'S EJECTION FRACTION WAS 55% PERCENT. ADDITIONAL INFORMATION RECEIVED DURING INVESTIGATION OF THIS EVENT INDICATES THIS PATIENT EXPIRED NINE DAYS POST TAVR. THE AUTOPSY REPORTED NO CARDIAC FINDINGS FOR DEATH. IT IS BELIEVED THE PATIENT HAD AN ILEUS, VOMITED AND ASPIRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97318 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 3125474

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R