BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 5232676 · Received November 18, 2015

    Report

    Report Number
    2015691-2015-03128
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. WITHOUT THE DEVICE RETURN, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. A REVIEW OF THE DHR, PHYSICIAN TRAINING MANUAL, IFUS AND PHOTOGRAPHS OF THE DEVICE WERE PERFORMED. DHR REVIEW DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. NO DEFICIENCIES WITH THE IFU OR TRAINING MANUAL WERE IDENTIFIED. DURING MANUFACTURING, THE DELIVERY SYSTEM UNDERGOES MULTIPLE 100% INSPECTIONS AND VERIFICATIONS. THESE INSPECTIONS SUPPORT THAT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE WAS THE SOURCE OF THE COMPLAINT. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTES TO THIS TYPE OF EVENT. THERE ARE EXTENSIVE MANUFACTURING INSPECTIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING PERFORMED TO EVERY MANUFACTURED LOT). THE THV DELIVERY SYSTEM BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST DUE TO CONTACT WITH A HIGHLY CALCIFIED ANNULUS. ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE WHEN THE INFLATED DELIVERY SYSTEM BALLOON COMES IN CONTACT WITH THE NATIVE ANNULAR CALCIFICATION AT FULL INFLATION/DEPLOYMENT. IN THIS CASE, THE COMPLAINT OF THE DELIVERY SYSTEM BALLOON BURST COULD NOT BE CONFIRMED BASED ON THE REVIEW OF THE DEVICE PHOTOGRAPH; HOWEVER, A SEPARATION OF THE INFLATION AND CRIMP BALLOONS WERE CONFIRMED BASED ON THE DEVICE PHOTOGRAPH. DUE TO THE UNAVAILABILITY OF THE DEVICE, IT CANNOT BE DETERMINED IF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENT. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. PROCEDURAL FACTORS (DURING VALVE DEPLOYMENT THE FLEX CATHETER HAD NOT BEEN WITHDRAWN) MAY HAVE CONTRIBUTED TO THIS EVENT. 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. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2015-03131.

    Description of Event or Problem · 1

    AS REPORTED BY OUR EDWARDS CANADIAN AFFILIATE, DURING THE DEPLOYMENT OF A 29MM SAPIEN XT VALVE VIA THE TRANSFEMORAL APPROACH, THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) BALLOON RUPTURED. FOLLOWING THE PLACEMENT OF AN ESHEATH IN THE RIGHT FEMORAL ARTERY, BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH CONTRAST INJECTION INDICATING AMPLE FLOW AROUND THE VALVE. DUE TO THE CONCERN THAT THE NATIVE ANNULUS MAY BE TOO LARGE, A 29MM NF+ DS WAS PREPARED WITH AN ADDITIONAL 2CC OF VOLUME. DURING ADVANCEMENT OF THE DS, DIFFICULTY ADVANCING THE SYSTEM OVER THE AORTIC ARCH WAS ENCOUNTERED, BUT THE DS WAS EVENTUALLY POSITIONED IN THE ANNULUS IN A GOOD POSITION. UNDER RAPID PACING, THE SAPIEN XT VALVE WAS SLOWLY INFLATED. DURING INFLATION, IT WAS OBSERVED THAT THE VALVE WAS NOT FULLY EXPANDED ON THE AORTIC END AND IT WAS NOTED THAT THE FLEX CATHETER HAD NOT BEEN WITHDRAWN. AT THIS POINT, THE DS BALLOON RUPTURED. THE VALVE WAS STABLE WITHIN THE ANNULUS, BUT NOT FULLY INFLATED WITH THE AORTIC END UNDER DEPLOYED BY 20%. DURING THE ATTEMPT TO REMOVE THE DS THROUGH THE ESHEATH, DIFFICULTIES WERE ENCOUNTERED. WHILE TRYING TO REMOVE THE DS AND SHEATH TOGETHER, THE ESHEATH WAS PULLED OUT OF THE PATIENT AND THE DS REMAINED. A VASCULAR SURGEON PERFORMED A CUTDOWN TO REMOVE THE DS. DURING THIS TIME, A SECOND SHEATH WAS PLACED IN THE LEFT FEMORAL ARTERY AND A SECOND DS WAS ADVANCED TO POST DILATE THE VALVE. THE NATIVE ANNULAR DIAMETER MEASURED 28MM BY TEE. INFORMATION CONCERNING THE ACCESS VESSEL MINIMUM LUMINAL DIAMETER (MLD) WAS NOT PROVIDED. SEVERE TORTUOSITY OF THE ACCESS VESSEL WAS REPORTED. IT WAS PERCEIVED THAT THE FLEX CATHETER NOT BEING PULLED BACK CONTRIBUTED TO THE DS BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763801 EDWARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29 60020873

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention