BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3172706 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20364
    Event Type
    Death
    Date Received
    June 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE¿S INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON AORTIC VALVULOPLASTY (BAV), THE USE OF BIOPROSTHETIC HEART VALVES, AND ANESTHESIA INCLUDE BUT ARE NOT LIMITED TO DEATH (PROCEDURE-RELATED, DEVICE-RELATED, OR UNKNOWN). IN THIS CASE, MULTIPLE INVESTIGATIONAL FOLLOW-UPS HAVE TAKEN PLACE; HOWEVER, TO DATE THE CAUSE OF DEATH FOR THIS PATIENT HAS NOT BEEN OBTAINED. THE FACILITY¿S RISK MANAGEMENT PERSONNEL INDICATED THAT BASED ON THE AUTOPSY REPORT THE PHYSICIAN TEAM THOUGHT THAT THE CAUSE OF DEATH WAS UNRELATED TO THE SAPIEN VALVE AND THEREFORE THE FACILITY WAS UNWILLING TO RELEASE ANY PATIENT INFORMATION. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE INSTRUCTIONS FOR USE (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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, SHE WAS INFORMED BY THE IMPLANT PHYSICIAN THE PATIENT HAD CODED AND EXPIRED ON THE EVENING OF THE TAVR PROCEDURE. THE PHYSICIAN INDICATED THE PATIENT'S CAUSE OF DEATH WAS UNKNOWN AND THAT AN AUTOPSY WOULD BE PERFORMED. THE PATIENT WAS SUCCESSFULLY EXTUBATED FOLLOWING TAVR AND WAS DOING WELL. HE STILL HAD A TEMPORARY PACER IN PLACE. THE PATIENT'S SUFFERED A VASOVAGAL SYNCOPE, HIS HEART RATE DECREASED, WAS HYPOTENSIVE AND ARRESTED. PER ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SPECIALIST: THERE WAS NO EVIDENCE OF VALVE DYSFUNCTION DURING THE PROCEDURE. THERE WAS NO PARAVALVULAR LEAK AND A BIT OF CENTRAL LEAK IMMEDIATELY POST IMPLANT WHICH HAD RESOLVED BY THE END OF THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT HAD BEEN DOING WELL ALL DAY FOLLOWING THE PROCEDURE. HE WAS EXTUBATED WITHOUT DIFFICULTY AND HAD BEEN SITTING UP IN BED AND EATING DINNER. THE TEMPORARY PACEMAKER HAD BEEN LEFT IN PLACE BECAUSE THERE WAS A JUNCTIONAL RHYTHM IMMEDIATELY POST VALVE IMPLANT WHICH HAD RETURNED TO NORMAL SINUS RHYTHM BY THE TIME HE LEFT THE PROCEDURE ROOM. AT APPROXIMATELY 9:15 IN THE EVENING OF THE PROCEDURE, HE COMPLAINED OF ABDOMINAL DISCOMFORT AND ASKED TO USE A BEDPAN. HE WAS BEARING DOWN FAIRLY HARD ON THE BEDPAN AND SUDDENLY ARRESTED. THE PATIENT¿S WIFE STATED THAT THEY HAD BEEN HAVING SOME DIFFICULTY WITH THE TELEMETRY SYSTEM AROUND THIS TIME SO IT IS UNCLEAR WHETHER ANY ARRHYTHMIA WAS NOTED. THE ICU TEAM WAS UNABLE TO RESUSCITATE THE PATIENT AND, AFTER APPROXIMATELY 45 MINUTES OF CPR, HE DIED. THE PHYSICIAN HAD ECHO LOOK AT THE HEART AND VALVE DURING THE RESUSCITATION ATTEMPT AND AT THE TIME OF THE ECHO, THE VALVE WAS STILL IN PLACE. AN AUTOPSY WAS PERFORMED AND THERE WAS NO EVIDENCE OF BLEEDING. THE VALVE HAD DISLODGED SOMETIME DURING THE CPR AND WAS IN THE LEFT VENTRICLE. THE PATHOLOGY REPORT WILL BE SUBMITTED AS SOON AS IT BECOMES AVAILABLE. THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274159 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A 3093701

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death