BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3120976 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20138
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED DEVICE SERIAL NUMBER AND DEVICE EXPIRATION DATE. UPDATED DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, PLEURAL EFFUSION IS A KNOWN COMPLICATION ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE MOST COMMON ETIOLOGIES FOR PLEURAL EFFUSIONS ARE CONGESTIVE HEART FAILURE, PNEUMONIA, AUTOIMMUNE DISEASE, AND PULMONARY EMBOLISM. SINCE A PLEURAL EFFUSION IS A MANIFESTATION OF ANOTHER ILLNESS, THE RISK FACTORS ARE THOSE OF THE UNDERLYING DISEASE. HOWEVER, SOME COMMON FACTORS THAT INCREASE THE RISK OF PLEURAL EFFUSION INCLUDE HEART ATTACK, RECENT HEART OR LUNG SURGERY, PERICARDITIS, CANCER, AND CERTAIN MEDICATIONS. IN THIS CASE, DURING THE ASSESSMENT AND TREATMENT OF THE LARGE PLEURAL EFFUSION A TENSION PNEUMOTHORAX DEVELOPED WHICH MOST LIKELY CAUSED THE PEA ARREST. 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 AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS TERRITORY MANAGER THAT APPROXIMATELY SIX DAYS POST TAVR THE PATIENT PASSED AWAY. FURTHER INFORMATION NOTED THAT THE PATIENT PRESENTED TO A LOCAL HOSPITAL ER, COMPLAINING OF ACUTE SHORTNESS OF BREATH. A CHEST X-RAY WAS PERFORMED AND REVEALED A LARGE PLEURAL BASED OPACIFICATION IN THE LEFT HEMITHORAX WITH A SECONDARY MASS EFFECT DEVIATING THE MEDIASTINAL STRUCTURES TO THE RIGHT. IT WAS NOTED THAT THE LOCULATED LEFT PLEURAL EFFUSION WAS A POSSIBLE POST PROCEDURAL COMPLICATION / HEMORRHAGE. THE ATTENDING PHYSICIAN PREPARED A CHEST TUBE. REPORTEDLY DURING THE PREPARATION OF THE CHEST TUBE THE PATIENT HAD A SUDDEN PEA ARREST. THE CHEST TUBE WAS PLACED AND THE PHYSICIAN NOTED A MASSIVE PNEUMOTHORAX AND 1300ML OF FRANK BLOOD RETURNED. DESPITE RESUSCITATION EFFORTS INCLUDING CPR AND INTUBATION, THE PATIENT¿S PULSE DID NOT RETURN AND THE PATIENT EXPIRED. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222577 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death