BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON CATHETER

    MDR report key: 3122984 · Received May 21, 2013

    Report

    Report Number
    2015691-2013-20141
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FOR THE VALVE IS FOUND IN REPORT NUMBER 2015691-2013-20115, AND THE MDR REPORT FOR THE FIRST DELIVERY SYSTEM CAN BE FOUND IN REPORT NUMBER 2015691-2013-20123. 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, THE ROOT CAUSE OF THE EVENT WAS INDICATED AS LIKELY DUE TO THE SEVERE CALCIFICATION IN THE PATIENTS STJ. 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    DURING A TRANSAPICAL TAVR PROCEDURE, THE DELIVERY SYSTEM BALLOON RUPTURED AT PEAK INFLATION DUE TO A SEVERELY CALCIFIED STJ. DUE TO RESIDUAL PARAVALVULAR LEAK, A SECOND DELIVERY SYSTEM/VALVE WAS ADVANCED THROUGH THE AORTIC VALVE PROSTHESIS AND THE VALVE WAS DEPLOYED 1/2 CELL STRUT LOWER THAN THE FIRST VALVE. THE BALLOON WAS INFLATED DURING RVP WITH SUBSEQUENT BALLOON RUPTURE AT PEAK INFLATION. BECAUSE OF THE EXTENT OF CALCIFICATION THE PATIENT HAD DEMONSTRATED THROUGHOUT HER BODY, IT WAS FELT THAT LIKELY THERE WAS SOME AREA OF CALCIUM THAT WAS RUPTURING THE BALLOONS. THIS MDR IS FOR THE 2ND DELIVERY SYSTEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224373 ASCENDRA BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention