BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA DELIVERY SYSTEM

    MDR report key: 3163382 · Received June 11, 2013

    Report

    Report Number
    2015691-2013-20316
    Event Type
    Injury
    Date Received
    June 11, 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

    THE DELIVERY DEVICE WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DELIVERY DEVICE WAS NOT COMPLETED/REQUIRED AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR OR VASCULAR INJURIES, SUCH AS PERFORATION OR DAMAGE OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE. CHORDAE TENDINAE RUPTURE IN TAVR CAN OCCUR DURING ADVANCEMENT OF THE BAV CATHETER OR DELIVERY SYSTEM AND IS MOST LIKELY TO OCCUR WITH THE TRANSAPICAL APPROACH. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. IN THIS CASE, THE MITRAL CHORD RUPTURE OCCURRED DURING THE INITIAL ATTEMPT AT VALVE CROSSING. 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 BY THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING THE TRANSAPICAL TAVR PROCEDURE, AFTER THE VALVE WAS DEPLOYED, A TEAR IN THE CHORDAE TENDINAE AND INJURY TO THE MITRAL VALVE (MV) WERE NOTED. CASE SUMMARY: AT THE BEGINNING OF THE PROCEDURE, THE PHYSICIAN REPORTED EXPERIENCING RESISTANCE WHILE ADVANCING THE DELIVERY SYSTEM. AFTER THE SAPIEN VALVE WAS DEPLOYED, A POST DEPLOYMENT ECHOCARDIOGRAM SHOWED SEVERE MR AND A RUPTURED MITRAL CHORDAE. THE TEAM THEN DECIDED TO CONVERT THE PATIENT TO OPEN CHEST SURGERY. BOTH THE MITRAL AND THE AORTIC VALVES WERE REPLACED WITH SURGICAL VALVES. PER REPORT, BOTH THE PATIENT¿S NATIVE AORTIC VALVE AND SAPIEN VALVE WERE EXPLANTED AND DESTROYED. ADDITIONAL INFORMATION PROVIDED BY THE CLINICAL SPECIALIST (CS), INDICATED THAT AT THE BEGINNING OF THE PROCEDURE, THE PHYSICIAN HAD EXPERIENCE DIFFICULTY WITH THE PUNCTURE ANGLE AT THE LEFT VENTRICLE APEX. IN ADDITION, THE TEAR IN THE CHORDATE TENDINAE, WHICH WAS CAUSED BY THE DELIVERY DEVICE, HAD RESULTED IN MITRAL REGURGITATION. POST VALVE DEPLOYMENT THE PATIENT HAD BECOME HYPOTENSIVE AND BRADYCARDIC. THE PATIENT WAS PLACED ON A PUMP AND WAS CONVERTED TO DOUBLE VALVE SURGERY. PER THE CS, THERE WAS NO ISSUE WITH THE SAPIEN VALVE, HOWEVER, ANATOMICALLY IN ORDER TO REPAIR/REPLACE THE MITRAL VALVE THE PHYSICIAN HAD TO CUT OUT THE NATIVE AORTIC VALVE. BOTH VALVES WERE REPLACED WITH SURGICAL VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264167 ASCENDRA DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES ASCENDRA DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention