BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2922538 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19141
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MANUFACTURING REPORT NUMBER 2015691-2013-19140 FOR THE FIRST VALVE IMPLANTED IN THIS PROCEDURE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. CINE AND ECHO IMAGES WERE SUBMITTED FOR REVIEW BY THE EDWARDS MEDICAL DIRECTOR; HOWEVER, THE CINE IMAGES WERE NOT READABLE AND THEREFORE WERE NOT REVIEWED. TEE WAS REVIEWED. OBSERVATIONS: TEE: BULKY NCC, SEVERE ON RCC, AND MOD-SEVERE ON LCC AORTIC VALVE CALCIFICATION, MODERATE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, LVOT 2.0CM, ANNULUS 2.0CM. FAIR COAXIAL ALIGNMENT OF DELIVERY SYSTEM. VALVE POSITIONED 50:50 THOUGH SLIGHTLY TILTED. DEPLOYED 50:50 WITH THE EDGE OF THE VALVE AT THE MITRAL HINGE POINT. POST DEPLOYMENT OF SAPIEN #1: NORMAL LEAFLET MOTION OFF RCC CUSP AND POSSIBLY LCC. HOWEVER, THE NCC CANNOT BE VISUALIZED. COLOR DOPPLER DURING DIASTOLE DEMONSTRATES CENTRAL AR. SECOND SAPIEN DEPLOYED MORE VENTRICULAR, THOUGH PER REPORT THIS WAS NOTED TO BE DEPLOYED MORE AORTIC. IT IS CLEAR ON TEE IMAGES THAT THE VENTRICULAR EDGE OF 2ND SAPIEN IS MORE VENTRICULAR WITHIN THE FIRST SAPIEN VALVE. POST 2ND VALVE DEPLOYMENT CPR IS PERFORMED AND CAPTURED ON TEE. LEAFLET OVERHANG IS DEMONSTRATED. COLOR DOPPLER DEMONSTRATES CENTRAL AR AND LCC APPEARS TO BE IMMOBILE. THIRD SAPIEN VALVE DEPLOYED MORE AORTIC WITH RESULTING REDUCTION IN AR AND ALL 3 FUNCTIONING LEAFLETS. IMPRESSIONS: POST DEPLOYMENT OF SAPIEN #1 THERE IS NORMAL LEAFLET MOTION OFF RCC CUSP AND POSSIBLY LCC HOWEVER; THE NCC CANNOT BE VISUALIZED. ALTHOUGH IT WAS REPORTED THAT THE 2ND VALVE WAS DEPLOYED MORE AORTIC, ON TEE THE 2ND SAPIEN VALVE IS DEPLOYED MORE VENTRICULAR WITH NOTED LEAFLET OVERHANG AND AN IMMOBILE LCC. A 3RD SAPIEN VALVE DEPLOYED MORE AORTIC WITH RESOLUTION OF AR. PER THE INSTRUCTIONS FOR USE AND THE PATIENT SCREENING MANUAL, VALVE REGURGITATION AND NATIVE VALVE LEAFLET OVERHANG WITH THE POTENTIAL TO IMPAIR SAPIEN LEAFLET FUNCTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX3 DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY THE SAPIEN VALVE BEING DEPLOYED TOO VENTRICULAR AND ABNORMALLY LONG NATIVE VALVE LEAFLETS AS FACTORS THAT CAN CONTRIBUTE TO REGURGITATION AND NATIVE LEAFLET OVERHANG. IN THIS CASE, IT APPEARS THAT NATIVE LEAFLET OVERHANG CONTRIBUTED TO THE IMPAIRED FUNCTION OF SAPIEN VALVE #2 AND SUBSEQUENT CAI. THE ROOT CAUSE OF THE DIFFICULTY WITH SAPIEN VALVE #1 IS UNCLEAR. 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 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, FOLLOWING DEPLOYMENT OF A 26MM SAPIEN VALVE A LEFT CORONARY CUSP (LCC) LEAK WAS NOTED WITH SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI). THE PHYSICIAN REPORTED THAT ONE LEAFLET WAS NOT FUNCTIONING. A SECOND SAPIEN VALVE WAS IMPLANTED WITHIN THE FIRST; HOWEVER, A LEAK WAS NOW NOTED ON THE RIGHT CORONARY CUSP (RCC) AND ANOTHER LEAFLET WAS NOTED TO NOT BE MOVING, RESULTING IN SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI). THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND COULD NOT BE MAINTAINED WITH DRUGS. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT WAS DEFIBRILLATED NUMEROUS TIMES. AN INTRAAORTIC BALLOON PUMP (IABP) WAS INSERTED. ON TEE THERE WAS ONLY 2 LEAFLETS NOTED TO BE SEEN AFTER THE SECOND VALVE WAS PLACED. AFTER MULTIPLE SHOCKS, CPR AND PHARMACOLOGICAL SUPPORT, THE PATIENT'S CONDITION STABILIZED. IN THE MEANTIME, THE SHEATH WAS REMOVED AND THE APEX WAS CLOSED. THE MEDICAL TEAM DECIDED THAT SINCE THE PATIENT WAS INOPERABLE AND HE HAD NO VESSEL ACCESS, THEY WOULD RE-STICK THE APEX. THEY KNEW AFTER THE DRUGS WOULD BE OUT OF THE PTS SYSTEM HE WOULD NOT BE ABLE TO TOLERATE THE CENTRAL AI WITHOUT ANOTHER VALVE. THE PATIENT WAS BEING SUPPORTED BY DRUGS AND IABP WHEN THE PHYSICIAN STUCK THE APEX AGAIN AND REINSERTED A NEW SHEATH. A THIRD SAPIEN VALVE WAS PLACED INSIDE THE OTHER TWO VALVES WITH A NICE RESULT. NO CAI OR PARAVALVULAR LEAK (PVL) WAS NOTED, AND ALL 3 LEAFLETS COULD BE VISUALIZED ON TEE. THE APEX WAS AGAIN CLOSED WITH NO COMPLICATIONS. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE INITIAL SAPIEN VALVE WAS POSITIONED AND IMPLANTED 50:50 ACROSS THE NATIVE AORTIC ANNULUS. THE SECOND SAPIEN VALVE WAS POSITIONED AND IMPLANTED 60:40 AORTIC. THE IMAGE INTENSIFIER ANGLE AND THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM WERE BOTH DESCRIBED AS GOOD. THE NATIVE AORTIC VALVE WAS MODERATELY CALCIFIED, WITH THE CALCIUM EVENLY DISTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27241 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention