BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN RETROFLEX3 DELIVERY SYSTEM

    MDR report key: 2922443 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19139
    Event Type
    Death
    Date Received
    January 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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, WHICH MAY REQUIRE INTERVENTION 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 AND FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, PER THE MEDICAL RECORDS, IT APPEARS THAT THE LEFT VENTRICULAR PERFORATION WAS MOST LIKELY CAUSED BY THE GUIDEWIRE USED DURING THE TAVR PROCEDURE. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AN IMPLANT PATIENT REGISTRY (IPR) CARD WAS RETURNED TO EDWARDS WITH A NOTE INDICATING THAT THE PATIENT HAD EXPIRED. THE CAUSE AND DATE OF DEATH WERE NOT PROVIDED. UPON INVESTIGATION, THE MEDICAL RECORDS PERTAINING TO THE PATIENT'S DEMISE WERE OBTAINED. PER THE DISCHARGE SUMMARY, "THE [TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)] PROCEDURE ITSELF WENT WELL, HOWEVER, IMMEDIATELY FOLLOWING IMPLANTATION OF THE VALVE, DURING REMOVAL OF THE FEMORAL SHEATH, THE PATIENT DEVELOPED SIGNIFICANT HEMODYNAMIC INSTABILITY. TRANSESOPHAGEAL ECHO CONFIRMED THE PRESENCE OF AN ENLARGING PERICARDIAL EFFUSION AND AN EMERGENT PERICARDIAL WINDOW WAS PERFORMED IN THE OPERATING ROOM. THE PATIENT DID HAVE A FAIR AMOUNT OF BLOOD EVACUATED FROM HIS PERICARDIUM, HOWEVER, ONCE EVACUATED, THE BLEEDING DID SEEM TO SUBSIDE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE HE DID WELL FOR APPROXIMATELY 24-36 HOURS. HE WAS EXTUBATED AND EVEN WAS UP OUT OF BED, HOWEVER ON THE EVENING OF POSTOPERATIVE DAY #1 HE DEVELOPED SIGNIFICANT BLEEDING AGAIN FROM HIS PERICARDIAL DRAIN WHICH WAS LEFT IN PLACE. HE WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR RE-EXPLORATION VIA FULL STERNOTOMY. THE PATIENT WAS FOUND TO HAVE A PERFORATION OF THE LEFT VENTRICULAR LATERAL WALL, MOST LIKELY FROM THE GUIDEWIRE USED DURING HIS PROCEDURE. MULTIPLE ATTEMPTS WERE MADE TO REPAIR THE INJURY WITHOUT SUCCESS AND THE PATIENT UNFORTUNATELY EXPIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27877 EDWARDS SAPIEN RETROFLEX3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death GUIDEWIRE