BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3467461 · Received November 13, 2013

    Report

    Report Number
    2015691-2013-21527
    Event Type
    Death
    Date Received
    November 13, 2013
    Date of Event
    August 4, 2013
    Report Date
    October 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED FROM FOLLOW UP WITH THE SITE¿S COMMERCIAL VALVE CLINIC COORDINATOR. THE POST TAVR ECHO SHOWED THE DEVICE TO BE FUNCTIONING WELL. PER REPORT,THE PATIENT¿S DEATH WAS NOT RELATED TO THE SAPIEN VALVE. THE PATIENT WAS EXTREMELY ILL TO START, REQUIRING PCI PRIOR TO PROCEDURE. SHE HAD A RESPIRATORY ARREST POST TAVR. SHE WENT TO THE OR FOR INTERCOSTAL BLEEDER AND DID OKAY INITIALLY. HOWEVER, SHE DEVELOPED SEPSIS HOWEVER AND SUCCUMBED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED TO THE EDWARDS IMPLANT PATIENT REGISTRY (IPR), THE PATIENT PASSED AWAY 5 DAYS POST TAVR PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN.IT WAS PREVIOUSLY REPORTED THAT THIS PATIENT EXPERIENCED HEART BLOCK POST VALVE DEPLOYMENT, AND WAS SCHEDULED TO HAVE A PERMANENT PACEMAKER (PPM) PLACED POST PROCEDURE (MDR REPORT #2015691-2013-020862). AS THE PATIENT¿S DEATH OCCURRED 5 DAYS POST PROCEDURE, IT IS UNKNOWN IF THE TWO EVENTS ARE RELATED.

    Description of Event or Problem · 1

    AS REPORTED TO THE EDWARDS IMPLANT PATIENT REGISTRY (IPR), THE PATIENT PASSED AWAY 5 DAYS POST TAVR PROCEDURE. ADDITIONAL FOLLOW UP REVEALS THE PATIENT WAS EXTREMELY ILL TO START, REQUIRING PCI PRIOR TO PROCEDURE. SHE HAD A RESPIRATORY ARREST POST TAVR. SHE WENT TO THE OR FOR INTERCOSTAL BLEEDER AND DID OKAY INITIALLY. HOWEVER, SHE DEVELOPED SEPSIS HOWEVER AND SUCCUMBED. THE POST PROCEDURE ECHO SHOWED THE VALVE TO BE FUNCTIONING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587111 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death