BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA+ DELIVERY SYSTEM, 29MM

    MDR report key: 4674240 · Received April 9, 2015

    Report

    Report Number
    2015691-2015-00804
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 18, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE ASCENDRA+ DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. UPON VISUAL INSPECTION, THE COMPLAINT WAS CONFIRMED. AN AXIAL BALLOON BURST/TEAR, APPROXIMATELY 1 INCH IN LENGTH FROM THE DISTAL END, AND A SMALL KINK ON THE PUSHER APPROXIMATELY 4.5 INCHES FROM THE DISTAL NOSE TIP, WERE OBSERVED. ADDITIONALLY, A KINK ON THE OUTERMOST TUBING, APPROXIMATELY 3.25 INCHES FROM THE DISTAL HUB WAS OBSERVED, WHICH WAS LIKELY DUE TO SHIPPING. NO POTENTIAL MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED BASED ON VISUAL INSPECTION. DUE TO THE STATE OF THE RETURNED DEVICE (BALLOON BURST), NO RELEVANT FUNCTIONAL ANALYSIS OF THE DEVICE WERE POSSIBLE. BASED ON THE VISUAL INSPECTION AND DIMENSIONAL ANALYSIS OF THE BALLOON WALL THICKNESS, NO POTENTIAL MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED. AS PART OF THE MANUFACTURING PROCESS, ALL ASCENDRA+ DELIVERY SYSTEMS UNDERGO 100% MANUFACTURING AND QUALITY INSPECTION, INCLUDING: INSPECTION UNDER A 2.5 X MICROSCOPE FOR ANY TEAR, KINKS, CRACKS OR HOLES, VERIFICATION OF BALLOON SIZE, VERIFICATION THAT THE DEFLATED BALLOON FITS PROPERLY INSIDE THE DISTAL BALLOON COVER. THESE INSPECTIONS STATED ABOVE SUPPORT THAT IT IS UNLIKELY 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 TECHNICAL SUMMARY. 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. BASED ON AVAILABLE INFORMATION AND THE DEVICE EVALUATION, THE PATIENT¿S HEAVILY CALCIFIED STJ AND SOV, AND MODERATELY CALCIFIED NATIVE ANNULUS CONTACTING THE FULLY INFLATED DELIVERY SYSTEM BALLOON IS A LIKELY CONTRIBUTING FACTOR TO THE BALLOON BURST. PROTRUDING MATERIAL FROM THE BURST INFLATION BALLOON IS A LIKELY CONTRIBUTING FACTOR FOR THE WITHDRAWAL DIFFICULTY OF THE DELIVERY SYSTEM THROUGH THE ESHEATH. THE COMPLAINT WAS CONFIRMED, BUT NO MANUFACTURING NON-CONFORMITIES WERE FOUND IN THE RETURNED SAMPLE. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF A 29MM SAPIEN XT VALVE, THE DELIVERY BALLOON RUPTURED AT MAXIMUM INFLATION. THERE WAS MODERATE RESISTANCE EXPERIENCED WHILE ATTEMPTING TO PULL THE DELIVERY SYSTEM INTO THE SHEATH, HOWEVER THE SYSTEM WAS SUCCESSFULLY REMOVED WITH MANIPULATION OF THE SHEATH. DURING A TRANSAPICAL TAVR PROCEDURE, BAV WAS PERFORMED WITH AN EDWARDS 20 X 3 BALLOON AND THE DELIVERY SYSTEM WAS PLACED IN THE ANNULUS. PACING WAS INITIATED, HOWEVER THE PATIENT¿S HEART RATE DID NOT EXCEED 120BPM AND THE BLOOD PRESSURE (BP) DID NOT DROP AS RECOMMENDED (APPROXIMATELY 105/60). DURING DEPLOYMENT OF THE 29MM SAPIEN XT VALVE, THE DELIVERY BALLOON RUPTURED AT MAXIMUM INFLATION. THE VALVE WAS SUCCESSFULLY DEPLOYED IN A 50:50 POSITION IN THE ANNULUS. THERE WAS MODERATE RESISTANCE EXPERIENCED WHILE ATTEMPTING TO PULL THE DELIVERY SYSTEM INTO THE SHEATH, HOWEVER THE SYSTEM COULD BE REMOVED WITH MANIPULATION OF THE SHEATH. SIMULTANEOUSLY WITH THE BALLOON BURST, THE PATIENT¿S RHYTHM CONVERTED TO SUSTAINED VENTRICULAR TACHYCARDIA, WHICH WAS SUCCESSFULLY CARDIOVERTED TO SINUS TACHYCARDIA WITH SYSTOLIC BP IN THE 40'S - 50'S; CPR AND MEDICAL RESUSCITATION WERE INITIATED. THE PATIENT¿S BP AND RHYTHM STABILIZED AND CPR WAS HALTED. LOSS OF CAPTURE WAS PERIODICALLY PREVALENT AND AN ATTEMPT WAS MADE TO PLACE EPICARDIAL LEADS AS THE TRANSVENOUS WIRE WAS REMOVED. THE PLACEMENT OF THE EPICARDIAL LEADS WAS NOT SUCCESSFUL AS PATIENT DEVELOPED A HIGH DEGREE AV BLOCK AND LOSS OF BP. THE TRANSVENOUS TPM WAS REINSERTED AND THE SURGICAL SITE WAS CLOSED. DUE TO THE INTERMITTENT LOSS OF CAPTURE A PERMANENT TRANSVENOUS PACEMAKER WAS PLACED. THE PATIENT HAD A HEAVILY CALCIFIED STJ AND SOV, AND MODERATELY CALCIFIED NATIVE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234077 ASCENDRA+ DELIVERY SYSTEM, 29MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355AS29 59765728

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR