BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESCIENCES RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 3011833 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19591
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT IS ONGOING. THIS REPORT IS ASSOCIATED WITH MEDWATCH REPORT # 2015691-2013-19590.

    Additional Manufacturer Narrative · 1

    PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON AORTIC VALVULOPLASTY (BAV) AND THE USE OF ANESTHESIA INCLUDE BUT ARE NOT LIMITED TO CARDIOVASCULAR INJURY INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION. IN THIS CASE, THERE WAS NO ALLEGATION OF AN EDWARD'S DEVICE MALFUNCTION CONTRIBUTING OR CAUSING THIS EVENT. IT IS LIKELY THAT PATIENT AND PROCEDURAL FACTORS CONTRIBUTED TO/CAUSED THE VENTRICULAR PERFORATION. PER REPORT, THE (B)(6) PATIENT HAD A SMALL LEFT VENTRICLE, AND A SEVERELY CALCIFIED AORTIC VALVE THAT WAS DIFFICULT TO CROSS WITH THE DELIVERY DEVICE DESPITE A STABLE BAV. THE REPORTER CONSIDERED IT POSSIBLE THAT THE RF3 DELIVERY SYSTEM PUSHED THROUGH THE VENTRICLE WHEN THE VALVE WAS BEING POSITIONED IN THE ANNULUS CAUSING THE VENTRICULAR PERFORATION. 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 IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED. THIS IS ONE OF THREE REPORTS SUBMITTED FOR THIS EVENT. PLEASE REFERENCE MANUFACTURER REPORTS: 2015691-2013-19590 (1ST VALVE), 2015691-2013-19591 (RF3 DELIVERY SYSTEM) AND COMPLAINT 2013-02333-1 WITH CORRESPONDING MANUFACTURER REPORT # 2015691-2013-19594 (2ND VALVE).

    Description of Event or Problem · 1

    PER THE EDWARDS LIFESCIENCES FIELD CLINICAL SPECIALIST REPORT, POST TRANSFEMORAL DEPLOYMENT, THE 23MM SAPIEN VALVE WAS DEPLOYED TOO AORTIC (70:30) CAUSING MODERATE-SEVERE AORTIC INSUFFICIENCY (AI). A 2ND SECOND 23MM SAPIEN VALVE WAS DEPLOYED IN GOOD POSITION (50:50) WITH NO AI ON ECHO. AS REPORTED, THE 1ST VALVE MOVED A LITTLE AORTIC DURING DEPLOYMENT BECAUSE IT WAS DEPLOYED IN A SUBOPTIMAL VIEW. PERICARDIAL EFFUSION WAS NOTED ON ECHO, WHICH WAS DUE TO LV PERFORATION CLOSE TO THE APEX. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE NATIVE AORTIC VALVE WITH THE RETROFLEX3 DELIVERY SYSTEM; IT IS NOT YET CLEAR IF BAV WAS PERFORMED FIRST. THE PATIENT HAD A SMALL LEFT VENTRICLE AND THE RF3 DELIVERY SYSTEM WAS PERCEIVED TO PUSH THROUGH THE VENTRICLE WHEN THE VALVE WAS BEING POSITIONED IN THE ANNULUS. THE SURGEON PERFORMED A PERICARDIAL WINDOW, EVACUATING 500CC OF BLOOD. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSPORTED TO ICU; HOWEVER, THEY PASSED AWAY 4 DAYS LATER. THE PHYSICIANS REPORTED THAT THE PATIENT HAD SEVERE AI ON ECHO 2 DAYS POST TAVR AND POSSIBLE BOWEL EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114488 EDWARDS LIFESCIENCES RETROFLEX 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23US 59339944

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention