BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA BALLOON CATHETER

    MDR report key: 3120872 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20131
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS INITIALLY REPORTED ON MANUFACTURING REPORT NUMBER 2015691-2013-19844 ON APRIL 18, 2013. TWO DELIVERY BALLOONS WITH THE SAME LOT NUMBER WERE NOTED TO HAVE BURST DURING THE SAME TAVR PROCEDURE. AFTER 2015691-2013-19844 WAS SUBMITTED, IT WAS DETERMINED THAT A SECOND MEDWATCH 3500A REPORT SHOULD BE FILED FOR THE SECOND DEVICE SUBMITTED IN THE PREVIOUS REPORT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. HISTORICAL THV BALLOON RUPTURE COMPLAINTS HAVE BEEN ANALYZED AND SUMMARIZED BY EDWARDS IN A TECHNICAL SUMMARY (TS). THE TS PROVIDES A RATIONALE AS TO WHY IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTES TO THIS TYPE OF EVENT, INCLUDING FACTORS ON WHY DEPLOYMENT OF BALLOONS ON THV DELIVERY SYSTEMS ARE SUBJECT TO INCREASED RISK OF BURST IN A CALCIFIED ANNULUS (OPEN CELL IMPINGEMENT AND STRESS CONCENTRATION AGAINST CALCIUM NODULES), AS WELL AS OUTLINING THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING THAT OCCURS WITH EVERY MANUFACTURED LOT). ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE. IN THIS CASE, THERE WAS SEVERE, BULKY CALCIFICATION ON THE NATIVE AORTIC VALVE. FROM THE INFORMATION AVAILABLE, IT APPEARS THAT AFTER THE BALLOON BURST A PIECE GOT CAUGHT IN THE SHEATH DURING RETRIEVAL, WHICH LED TO THE SEPARATION OF A PIECE OF THE BALLOON INSIDE THE SHEATH. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE DELIVERY BALLOON BURST DURING INFLATION AFTER TWO SECONDS. THE DELIVERY SYSTEM WAS REMOVED, AND A NEW DELIVERY SYSTEM WAS POSITIONED INSIDE THE SAPIEN VALVE AND INFLATED. THE SECOND DELIVERY BALLOON BURST AFTER 3 SECONDS. UPON PARTIAL REMOVAL OF THE SECOND DELIVERY SYSTEM, IT WAS NOTED THAT OUTSIDE THE SHEATH THERE WAS ONLY A SMALL PORTION OF THE BALLOON ATTACHED TO THE DELIVERY SYSTEM. FLUOROSCOPY REVEALED NO EVIDENCE OF THE REMAINDER OF THE BALLOON ANYWHERE IN THE PATIENT¿S BODY. AFTER REMOVAL OF THE ENTIRE DELIVERY SYSTEM, THE REMAINDER OF THE BALLOON WAS FOUND INSIDE THE SHEATH, STILL ATTACHED TO THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221676 ASCENDRA BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL23 59415670

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR