BEUDAMED
    FDA Adverse Event Death Summary report: N

    RETROFLEX 3 SAPIEN DELIVERY SYSTEM

    MDR report key: 3182250 · Received June 21, 2013

    Report

    Report Number
    2015691-2013-20400
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THE DEFINITIVE CAUSE OF THE PERFORATION COULD NOT BE DETERMINED; HOWEVER AS REPORTED THE GUIDEWIRE LIKELY CAUSED OR CONTRIBUTED TO THE PERFORATION OF THE LEFT VENTRICLE. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT POST TRANSFEMORAL VALVE DEPLOYMENT THE PATIENT BECAME SEVERELY HYPOTENSIVE WITH A SBP IN THE 40'S. THE PATIENT WAS GIVEN EPINEPHRINE WITH NO IMPROVEMENT NOTED ON THE MONITOR BY ANESTHESIA. THE ECHO REVEALED A SMALL YET GROWING EFFUSION AND SLUGGISH LV MOTION. THE PLACEMENT/FUNCTION OF THE VALVE WAS DEEMED GOOD PER ECHO. THE TEAM INITIALLY SUSPECTED AN AORTIC ROOT RUPTURE AND INITIATED CPR WHILE PREPARING TO GO ON BY-PASS. THE PATIENT WAS SUCCESSFULLY PLACED ON BY-PASS AND THE DECISION WAS MADE TO OPEN THE CHEST AND ATTEMPT TO REPAIR THE ROOT. ONCE THE CHEST WAS OPENED IT WAS DETERMINED THAT THE ROOT WAS INTACT WITH NO SIGNS OF RUPTURE/DISSECTION. THE SURGEON DISCOVERED A TEAR IN THE LV WITH THE PATIENT IN CARDIAC TAMPONADE. IT WAS DETERMINED THAT THE GUIDE WIRE CAUSED THE TEAR. WHILE REPAIRING THE TEAR THE CX ARTERY WAS DAMAGED AND SUBSEQUENTLY BYPASSED. DESPITE THEIR EFFORTS THE PATIENT FAILED TO STABILIZE AND WAS WEANED OFF BYPASS TO SEE HOW SHE WOULD DO. THE PATIENT EXPIRED ON THE TABLE SHORTLY AFTER COMING OFF PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283837 RETROFLEX 3 SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death AMPLATZ EXTRA STIFF WIRE