BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 3024229 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19675
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE'S INSTRUCTIONS FOR USE COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON AORTIC VALVULOPLASTY (BAV) AND THE USE OF ANESTHESIA INCLUDE BUT ARE NOT LIMITED TO MITRAL VALVE IMPAIRMENT/DAMAGE. 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. IN THIS CASE, THE EVENT OCCURRED DURING A TRANSFEMORAL CASE, HOWEVER THE CLINICAL SPECIALIST INDICATED THE RF3 DELIVERY SYSTEM DID NOT MALFUNCTION; THE EVENT WAS DEEMED A PROCEDURAL COMPLICATION. THE PATIENT DID NOT REQUIRE ADDITIONAL INTERVENTION, AND WAS DISCHARGED FROM THE TAVR PROCEDURE. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. 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 MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE THE MITRAL VALVE CHORDAE WAS TORN. NO ADDITIONAL INTERVENTION WAS REQUIRED. PER REPORT, THE SAPIEN VALVE WAS ADVANCED WITHOUT ISSUE. WHILE POSITIONING THE VALVE TO THE DEPLOYMENT POSITION, THE PHYSICIAN HAD DIFFICULTY BRINGING THE VALVE BACK TOWARDS THE AORTA. THE VALVE WAS DEPLOYED WITHOUT ISSUE. FOLLOWING DEPLOYMENT, THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED CORRECT VALVE PLACEMENT, TRACE PARAVALVULAR LEAK AND A FLAILING CHORDAE TO THE ANTERIOR MITRAL VALVE LEAFLET WITH MODERATE TO SEVERE MITRAL REGURGITATION (MR); THE PRE-PROCEDURE MR WAS TRACE. A RIGHT HEART CATH WAS PERFORMED TO ASSESS RIGHT HEART PRESSURES. THE CONDITION WAS CONSIDERED STABLE AND NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126929 RETROFLEX 3/SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R