BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON CATHETER

    MDR report key: 3161863 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20310
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING VASCULAR AND APICAL ACCESS, USE OF ANGIOGRAPHY, BALLOON VALVULOPLASTY, USE OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE BIO-PROSTHESIS IMPLANTATION. PATIENTS UNDERGOING THE TAVR PROCEDURE CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. PATIENT RISK FACTORS FOR HYPOTENSION INCLUDE LOW EF, CAD, CHF, ARTERIOSCLEROSIS, HYPOVOLEMIA, AND ANEMIA. ADDITIONALLY, THESE PATIENTS ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE INTENTIONALLY MADE HYPOTENSIVE, UTILIZING RAPID VENTRICULAR PACING, TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE HYPOTENSION IS VERY COMMON AND IS TREATED WITH STANDARD THERAPIES, INCLUDING VASOACTIVE DRUGS. IT IS ALSO NOT UNCOMMON TO INITIATE BRIEF CHEST COMPRESSIONS OR CARDIAC MASSAGE TO FACILITATE DISTRIBUTION OF THESE VASOACTIVE DRUGS. IN SOME CASES, THESE STANDARD MANEUVERS ARE NOT ADEQUATE, AND INITIATION OF CARDIOPULMONARY BYPASS (CPB), INSERTION OF IABP, AND/OR CONVERSION TO OPEN SURGERY IS REQUIRED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. AS A PRECAUTION, THE THV TRAINING MANUALS INSTRUCT THE OPERATOR TO MINIMIZE THE NUMBER AND DURATION OF RAPID BURST PACING EPISODES, AND ALLOW SUFFICIENT HEMODYNAMIC RECOVERY BEFORE INITIATING ANOTHER EPISODE OF RAPID PACING. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. 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. IN THIS CASE, THE CAUSE OF THE HYPOTENSION WAS LIKELY RELATED TO THE PROCEDURE/PACING, AND THE ROOT CAUSE OF THE BALLOON BURST WAS LIKELY DUE TO THE PATIENT¿ S SEVERE NATIVE VALVE CALCIFICATION. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSAPICAL TAVR PROCEDURE, THE VALVE WAS INSERTED AND WHILE CHECKING THE POSITION WITH THE PACER, THE PATIENT¿S PRESSURE DROPPED TO THE LOWER 40'S AND WAS NOT RECOVERING. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED AND THE PATIENT¿S PRESSURE RECOVERED TO ABOVE 120 MMHG. THE VALVE WAS DEPLOYED AND DURING DEPLOYMENT THE DELIVERY SYSTEM BALLOON BURST. THE VALVE WAS POST DILATED AND FINAL ECHO SHOWING MODERATE PARA-VALVULAR LEAK AND TRACE AI. THE PATIENT HAD SEVERE NATIVE VALVE/LEAFLET CALCIFICATION AND MODERATE AORTIC ROOT CALCIFICATION WITH AN EJECTION FRACTION OF 59%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262963 ASCENDRA BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL26 59457659

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention