BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER

    MDR report key: 3160244 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20302
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), INJURY TO THE MITRAL VALVE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. CHORDAE TENDINAE RUPTURE IN TAVR CAN OCCUR DURING ADVANCEMENT OF THE GUIDEWIRE, BAV CATHETER, OR DELIVERY SYSTEM AND IS MOST LIKELY TO OCCUR WITH THE TRANSAPICAL APPROACH. IN MOST CASES THIS CONDITION DOES NOT REQUIRE INTERVENTION. IF THE RUPTURE IS SIGNIFICANT IT TYPICALLY RESULTS IN PROFOUND MITRAL REGURGITATION AND WILL REQUIRE INTERVENTION TO PREVENT PERMANENT INJURY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, AFTER GAINING LV ACCESS WITH THE 035¿ SOFT GUIDEWIRE, THE WIRE SHOULD BE JIGGLED UNDER TEE IMAGING OF THE MITRAL VALVE. AN INCREASE IN MR SUGGESTS WIRE ENTANGLEMENT IN THE MITRAL SUB-VALVULAR APPARATUS. IF ENTANGLEMENT IS SUSPECTED: THE GUIDEWIRE SHOULD BE COMPLETELY REMOVED FROM THE VENTRICLE; THE OPERATOR SHOULD CHANGE DIRECTION OF NEEDLE AND REINSERT THE GUIDEWIRE INTO VENTRICLE, CHECKING AGAIN FOR WIRE ENTANGLEMENT. IN THIS CASE, THE CAUSE OF THE REPORTED MITRAL CHORDAE RUPTURE CANNOT BE CONFIRMED; HOWEVER, PER REPORT WHILE TRYING TO CROSS THE VALVE WITH THE WIRE THE ECHO IMAGES SHOWED THE WIRE GOING TOWARDS THE MITRAL VALVE AND THE WIRE WAS REPOSITIONED. IN ADDITION THE PHYSICIANS NOTED DIFFICULTY WHEN THEY WERE TRYING TO ADVANCE THE VALVE. IT IS POSSIBLE THAT THE GUIDE WIRE HAD BECOME ENTANGLED WITHIN THE MITRAL CHORDAE PRIOR TO ADVANCING THE DELIVERY SYSTEM. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; HOWEVER, THE EVENT WAS NOT CONSIDERED TO BE RELATED TO A MALFUNCTION OF THE DELIVERY SYSTEM. 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 BY THE EDWARDS LIFESCIENCES CLINICAL SPECIALIST, DURING A TRANSAPICAL TAVR PROCEDURE WITH THE ASCENDRA DELIVERY SYSTEM, A MITRAL CHORDAE RUPTURE OCCURRED. THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY TO REPAIR THE MITRAL VALVE. DURING DEVICE POSITIONING, ECHO INDICATED THE WIRE PATH WAS GOING IN THE DIRECTION OF THE MITRAL VALVE. THE WIRE POSITIONING WAS ADJUSTED AND IT APPEARED TO LOOK GOOD ON ECHO. THE PHYSICIANS NOTED DIFFICULTY DURING VALVE DELIVERY BUT IT WAS ABLE TO BE DEPLOYED IN A 60:40 AORTIC POSITION. WHEN THE PATIENT WAS CONVERTED TO AN OPEN PROCEDURE, THE SURGEON CONFIRMED THE SEVERED MITRAL CHORDAE. DURING THE REPAIR, THE SAPIEN WAS EXPLANTED DUE TO THE ¿ANATOMICAL SITUATION OF THE AORTIC AND MITRAL VALVES¿; THE SURGEON COULD NOT REPLACE THE MITRAL VALVE WITH A SURGICAL BIOPROSTHESIS WITHOUT REMOVING THE SAPIEN VALVE FIRST. THERE WAS NO ALLEGATION OF A SAPIEN VALVE MALFUNCTION. NO FURTHER ADVERSE EVENTS WERE REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261171 ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL26 59401333

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention