BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 23MM

    MDR report key: 3091912 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-19983
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 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, IT WAS REPORTED THAT THE VENTRICULAR PERFORATION WAS CAUSED BY THE (NON-EDWARDS) GUIDE WIRE. 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; THEREFORE, NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE, A VENTRICULAR PERFORATION OCCURRED. BAV WAS PERFORMED WITH A 22 X 5 ZMED II BALLOON. THE PATIENT'S PRESSURE REMAINED LOW. A SAPIEN VALVE WAS DEPLOYED UNDER RVP IN A 40/60 VENTRICULAR FINAL POSITION. THE PATIENT'S PRESSURE NEVER RETURNED AND CPR WAS INITIATED. A BALLOON PUMP WAS INSERTED AND A PERICARDIAL EFFUSION WAS NOTED ON TEE. THE DECISION WAS MADE TO OPEN REPAIR THE PERFORATION AND EFFUSION. ONCE THE PATIENT WAS STABILIZED A MODERATE PVL WAS NOTED ON TEE. THE DECISION WAS MADE TO IMPLANT A SECOND VALVE. THE SECOND VALVE WAS PREPPED, INSERTED AND POSITIONED IN THE FIRST VALVE. UNDER RVP THE VALVE WAS DEPLOYED SUPERIOR TO THE FIRST VALVE. UNDER TEE NO PVL OR CENTRAL LEAK WAS NOTED AND THE PATIENT'S BP REMAINED ABOVE 110MMHG SYSTOLIC. SURGICAL CLOSER OF THE STERNOTOMY WAS PERFORMED AND THE PATIENT WAS TRANSPORTED TO THE ICU IN STABLE CONDITION. ADDITIONAL INFORMATION REVEALS THAT THE PHYSICIAN FELT THE ROOT CAUSE OF PATIENT DECOMPENSATION WAS THE WIRE PERFORATING THE VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193693 RETROFLEX 3/SAPIEN DELIVERY SYSTEM - 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention