BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON CATHETER

    MDR report key: 3190654 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20426
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE¿S INSTRUCTIONS FOR USE (IFU) COMPLICATIONS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY (BAV) AND TRANSCATHETER VALVE REPLACEMENT INCLUDE, BUT ARE NOT LIMITED TO, INJURY TO THE MITRAL VALVE. PER THE IFU, DIFFICULTY CROSSING THE NATIVE VALVE MAY BE DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS, INCLUDING HEAVY CALCIFICATION, WIRE BIAS INTO COMMISSURES, HORIZONTAL AORTA, TORTUOUS THORACIC AORTA, FLEX CATHETER KINKED, AND INCOMPLETE BAV. IN MOST INSTANCES THIS RESOLVES WITH ROUTINE TROUBLESHOOTING MANEUVERS, WITH MINIMAL RISK TO THE PATIENT. A CHORDAE TENDINAE RUPTURE DURING TAVR CAN OCCUR DURING ADVANCEMENT OF THE GUIDEWIRE, BAV CATHETER, OR DELIVERY SYSTEM AND IS MOST LIKELY TO OCCUR WITH THE TRANSAPICAL APPROACH. THE ASCENDRA PROCEDURAL TRAINING MANUAL INDICATES THAT DURING THE CASE THE GUIDEWIRE SHOULD BE JIGGLED UNDER TEE IMAGING OF THE MITRAL VALVE. IT CAUTIONS THAT AN INCREASE IN MR OR DECREASE IN MITRAL LEAFLET MOBILITY SUGGESTS WIRE ENTANGLEMENT IN THE MITRAL SUB-VALVULAR APPARATUS. IF ENTANGLEMENT IS SUSPECTED THE GUIDEWIRE SHOULD BE REMOVED FROM THE VENTRICLE, THE DIRECTION OF THE WIRE SHOULD BE CHANGED, AND TO THEN REINSERT THE GUIDEWIRE INTO THE VENTRICLE CHECKING AGAIN FOR WIRE ENTANGLEMENT. IN THIS CASE, IT IS POSSIBLE PATIENT FACTORS (SEVERE MITRAL REGURGITATION) AND PROCEDURAL FACTORS (LIMITED ECHO VISIBILITY SECONDARY TO MITRAL REGURGITATION) LED TO THE REPORTED CROSSING DIFFICULTY AND CHORDAE ENTANGLEMENT. THERE IS NO EVIDENCE THAT SUGGESTS THE ASCENDRA DELIVERY DEVICE MALFUNCTIONED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR CASE THERE WAS DIFFICULTY CROSSING THE NATIVE ANNULUS WITH THE ASCENDRA DELIVERY SYSTEM WHICH REQUIRED CONVERSION TO SURGICAL AORTIC VALVE REPLACEMENT. PER REPORT, THIS PATIENT HAD 4+ MITRAL REGURGITATION AND A HYPERTROPHIC THICK WALLED LEFT VENTRICLE. LEFT THORACOTOMY WAS PERFORMED IN USUAL FASHION. ACCESSING THE AORTA FROM THE LEFT VENTRICLE PUNCTURE WAS VERY DIFFICULT. AFTER ECHO GUIDANCE THE WIRE WAS PLACED IN THE INFRA RENAL AORTA. IT APPEARED THAT THE WIRE WAS INVOLVED WITH THE MITRAL CHORDAE TENDINAE BUT ECHO REVEALED THE MITRAL VALVE WAS FUNCTIONING WITHOUT INTERFERENCE. THE BALLOON VALVULOPLASTY CATHETER WAS ADVANCED OVER WIRE WITH RESISTANCE. AGAIN, THE ECHO WAS REVIEWED TO MAKE SURE THE CHORDAE TENDINAE AND MITRAL LEAFLETS WERE NOT INVOLVED. BAV WAS PERFORMED WITHOUT ISSUES. THE 23MM SAPIEN VALVE ON THE ASCENDRA DELIVERY SYSTEM WAS ADVANCED THROUGH THE SHEATH. ONCE OUT THE DISTAL END OF SHEATH, THE VALVE WAS UNSTABLE IN THE AORTIC ANNULUS AND IT WAS APPARENT THAT THE WIRE AND VALVE WERE INDEED TIED-UP IN THE CHORDAE. THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT THE VALVE AND DELIVERY SYSTEM INTO THE SHEATH WITHOUT DAMAGING THE CHORDAE. AFTER SEVERAL FAILED ATTEMPTS TO ADVANCE/RETRACT/DISLODGE THE VALVE FROM THE CHORDAE, THE PATIENT WAS PLACED ON PERIPHERAL BYPASS. MORE AGGRESSIVE ADVANCEMENT/RETRACTION WAS PERFORMED WITHOUT SUCCESS. A DECISION WAS MADE TO SLIGHTLY INFLATE THE VALVE THEN DEFLATE THE BALLOON AND PULL THE DELIVERY SYSTEM, WIRE AND SHEATH OUT OF THE LEFT VENTRICLE LEAVING THE SEMI-DEPLOYED VALVE IN THE LEFT VENTRICLE BECAUSE THE PHYSICIAN DID NOT WANT TO DISRUPT THE CHORDAE. THE PATIENT WAS THEN CONVERTED TO TRADITIONAL SURGICAL AORTIC VALVE REPLACEMENT. THE PATIENT WAS STABLE THROUGHOUT THE ENTIRE PROCEDURE AND LEFT THE OPERATING ROOM IN STABLE CONDITION. THIS EVENT WAS ATTRIBUTED TO THE PATIENT¿S SEVERE MITRAL REGURGITATION WHICH INTERFERED WITH BEING ABLE TO ACCURATELY REVIEW ECHO. IF NOT FOR SEVERE MITRAL REGURGITATION, THE PHYSICIAN WOULD HAVE BEEN ABLE TO CLEARLY VIEW THE CHORDAE INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291567 ASCENDRA BALLOON CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL23 59444824

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention