BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 SAPIEN DELIVERY SYSTEM

    MDR report key: 3092667 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-20000
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETROFLEX3 DELIVERY SYSTEM WAS RETURNED TO EDWARDS IN A USED CONDITION. VISUAL INSPECTION OF THE DELIVERY SYSTEM DID NOT REVEAL ANY ABNORMALITIES. NO DAMAGE WAS OBSERVED AT THE DISTAL TIP, DISTAL LASER BOND, NOSE CONE, OR THE BALLOON. THE BALLOON WAS THEN INFLATED TO NOMINAL SIZE. NO LEAKS WERE OBSERVED AND THE BALLOON COULD MAINTAIN PRESSURE. THE DELIVERY SYSTEM WAS THEN FULLY FLEXED AND UNFLEXED WITH NO ISSUES OR ABNORMALITIES OBSERVED. THE COMPLAINT COULD NOT BE CONFIRMED AND NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED ON THE DELIVERY SYSTEM. THE ALLEGED TEAR ON THE BALLOON WAS NOT OBSERVED. POSSIBLE ANATOMICAL FACTORS OF THE AORTA OR PROCEDURAL FACTORS (AMOUNT OF FLEXION ON THE CATHETER) MAY HAVE CONTRIBUTED TO THE COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS ABLE TO BE RETRIEVED FROM THE VALVE WITH SOME EXTRA MANIPULATION. 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. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDS THE APRIL 2013 CONTROL LIMITS FOR THIS FAILURE MODE. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT AFTER SUCCESSFUL DEPLOYMENT OF A 23MM SAPIEN VALVE, DIFFICULTY OCCURRED DURING WITHDRAWAL OF THE DELIVERY SYSTEM. WHILE ATTEMPTING TO PULL THE BALLOON BACK OUT OF THE VALVE IT APPEARED THAT THE PROXIMAL EDGE OF THE NOSE CONE WAS GETTING HUNG UP ON THE STENT FRAME OF THE VALVE, ON THE RIGHT CORONARY SIDE. THE PHYSICIAN WAS ABLE TO FREE THE DELIVERY SYSTEM AFTER SEVERAL MANIPULATIONS. ECHO SHOWED TRACE PVL HOWEVER THERE WAS MODERATE CENTRAL AI. PER ECHO, ALL 3 LEAFLETS WERE COAPTATING, HOWEVER THERE WAS AN AREA THAT SHOWED THERE MAY BE AN ISSUE WITH ONE OF THE LEAFLETS AND THAT IS WHERE THE CENTRAL LEAK WAS AS WELL. A SECOND 23MM VALVE WAS PREPPED AND DELIVERED IN THE SAME POSITION. POST ECHO SHOWED NO CENTRAL OR PVL LEAK. IT WAS REPORTED THAT THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194152 RETROFLEX 3 SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59100195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention