BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON AORTIC VAVULOPLASTY CATHETER

    MDR report key: 3033162 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19722
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), REGURGITATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE AND BALLOON VALVULOPLASTY. IN THIS CASE, PER REPORT, THE PATIENT'S POOR HEMODYNAMICS POST BAV WERE ATTRIBUTED TO THE PATIENT'S CONDITION, SPECIFICALLY THE LOW EJECTION FRACTION. 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 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 PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), POST BALLOON AORTIC VALVULOPLASTY (BAV), THE PATIENT HAD WIDE OPEN AI. THE PATIENT HAD A BASELINE EF OF 20-25%, HE WAS PUT ON BYPASS AND HIS HEMODYNAMICS STABILIZED. AFTER SUCCESSFUL VALVE DEPLOYMENT THE PATIENT WAS WEANED OFF BYPASS, AND LEFT THE ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135748 ASCENDRA BALLOON AORTIC VAVULOPLASTY CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL26

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention