BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 6980770 · Received October 26, 2017

    Report

    Report Number
    2015691-2017-03578
    Event Type
    Death
    Date Received
    October 26, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 12, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS CASE THE CAUSE OF DEATH IS UNKNOWN; HOWEVER, IT COULD BE RELATED TO THE PATIENT¿S ADVANCED AGE ((B))(6)) AND PROCEDURAL FACTORS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A RELATIONSHIP EXISTED BETWEEN THE PATIENT¿S DEATH AND THE IMPLANTED VALVE. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. 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. DEATH IS LISTED IN THE INSTRUCTIONS FOR USE FOR THE TAVR PROCEDURE AND ARE KNOWN POTENTIAL RISKS ASSOCIATED WITH THE PROCEDURE. THERE IS NO ALLEGATION OF AN EDWARDS DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, IS INDICATED FOR PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC OR MITRAL VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., PREDICTED RISK OF SURGICAL MORTALITY = 8% AT 30 DAYS, BASED ON THE STS RISK SCORE AND OTHER CLINICAL CO-MORBIDITIES UNMEASURED BY THE STS RISK CALCULATOR). DEATH IS LISTED THE IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL RISK ASSOCIATED WITH THE TAVR PROCEDURE. IN THIS CASE THE CAUSE OF DEATH IS UNKNOWN; HOWEVER, IT COULD BE RELATED TO THE PATIENT¿S UNKNOWN (CO-MORBIDITIES AND PROCEDURAL FACTORS (INTOLERANCE TO ANESTHESIA AND/OR RAPID VENTRICULAR PACING). THERE IS INSUFFICIENT INFORMATION (PATIENT FACTORS, PROCEDURAL IMAGES FOR REVIEW) TO DETERMINE THE ROOT CAUSE OF THE PATIENT¿S INTRA-PROCEDURAL DEATH. ATTEMPTS TO INVESTIGATE AND GATHER PERTINENT INFORMATION (PROCEDURAL MEDICAL RECORDS, PROCEDURAL IMAGES) REGARDING THIS CASE WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    AS REPORTED THROUGH OUR BRITISH AFFILIATE, AFTER THE IMPLANT OF A 26MM SAPIEN 3 VALVE IN THE MITRAL POSITION INSIDE A SURGICAL VALVE (VALVE IN VALVE PROCEDURE) THE PATIENT EXPIRED. POST VALVE DEPLOYMENT, THE PATIENT¿S BLOOD PRESSURE DROPPED AND FOLLOWED INTO A VENTRICULAR FIBRILLATION. DESPITE RESUSCITATION NO UNDERLYING RHYTHM COULD BE OBTAINED. THE PATIENT PASSED AWAY DURING THE PROCEDURE. POST PROCEDURAL DISCUSSION TOOK PLACE AMONGST THE TEAM BUT THERE WAS NO DEFINITIVE CONCLUSION REACHED THAT LED TO THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    POST PROCEDURAL DISCUSSION TOOK PLACE AMONGST THE TEAM BUT THERE WAS NO DEFINITIVE CONCLUSION WAS REACHED REGARDING THE CAUSE OF THE PATIENT¿S INTRA-PROCEDURAL DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760228 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death