BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3191642 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20436
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 31, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, PARAVALVULAR LEAK AND CARDIOVASCULAR INJURY INCLUDING PERFORATION OR DISSECTION OF VESSELS, WHICH MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TAVR PROCEDURE. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. MANY CASES ARE MILD TO MODERATE ((B)(4)), AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. 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. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. ACCORDING TO THE THV TRAINING MANUAL, RISK FACTORS FOR ACUTE AORTIC RUPTURE/DISSECTION IN THE TAVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING ((B)(4)) IN THE PRESENCE OF SEVERELY CALCIFIED AORTIC ROOT AND OBLITERATED SINUSES. WHILE THE SAPIEN HEART VALVE RELIES ON NATIVE VALVE CALCIUM TO SECURELY ANCHOR TO THE ANNULUS, DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR THE EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. IN THIS CASE, THE EXACT CAUSE FOR THE PERICARDIAL EFFUSION CANNOT BE DETERMINED. THERE WAS NO REPORT OF A PROCEDURAL COMPLICATION WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE PERICARDIAL EFFUSION. PER REPORT, THE EFFUSION WAS ATTRIBUTED TO A CONCOMITANT DEVICE AND NOT THE EDWARDS VALVE OR 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 AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CLARIFICATION WAS RECEIVED FROM THE EDWARDS FIELD CLINICAL SPECIALIST INDICATING THE PERICARDIAL EFFUSION WAS ATTRIBUTED TO THE CHEST TUBE AND NOT THE SAPIEN VALVE. THE LOCATION OF THE EFFUSION WAS ON THE POSTERIOR SIDE OF THE HEART WHERE IT IS COMMON TO GET THEM FOLLOWING CHEST TUBE REMOVAL.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, ONE DAY POST TRANSAPICAL TAVR THERE WAS INCREASED PARAVALVULAR LEAK AND A PERICARDIAL EFFUSION WAS NOTED ON ECHO. PER REPORT, ON POST-OPERATIVE DAY 1 THE PATIENT WAS SHORT OF BREATH. THE PHYSICIANS DECIDED TO RE-INTUBATE THE PATIENT AND ADMINISTER NOREPINEPHRINE, EPINEPHRINE, AND VASOPRESSORS. A FOLLOW-UP ECHO WAS DONE TWO DAYS LATER, THERE WAS SEVERE MITRAL REGURGITATION, 3+ PARAVALVULAR LEAK AND A POSTERIOR PERICARDIAL EFFUSION; 600 CC¿S OF FLUID WERE REMOVED. THE PATIENT IMPROVED BY POST-OPERATIVE DAY 4. HOWEVER, DUE TO POOR PRESSURES, THE PATIENT WAS PLACED ON INTRA AORTIC BALLOON PUMP (IABP) AND A BAV WITH 23.8 CC WAS DONE IN ORDER TO REDUCE THE PVL; THE PVL WAS REDUCED FROM 3+ TO TRACE. AFTERWARDS THE PATIENT WAS WEANED OFF THE IABP, VASOPRESSORS AND ANOTHER 50-80 CC¿S WERE DRAINED FROM THE PREVIOUS EFFUSION. BY POST-OP DAY 11, THE PATIENT WAS EXTUBATED AND IN STABLE CONDITION. DURING THE INDEX PROCEDURE THE BALLOON VALVULOPLASTY (BAV) WAS PERFORMED WITH A 23MM X 3CM EDWARDS ASCENDRA BALLOON. OPEN THORACOTOMY ACCESS WAS OBTAINED IN THE 6TH INTERCOSTAL SPACE. MATTRESS SUTURES WERE PLACED IN THE MYOCARDIAL BARE SPOT AND THE 26MM SAPIEN VALVE WAS PREPPED WITH 21 CC. ONCE APICAL ACCESS WAS OBTAINED, THE ASCENDRA SHEATH WAS INSERTED OVER THE AMPLATZ WIRE INTO THE LVOT AT A DEPTH OF 4 CM. THE SAPIEN DEVICE WAS POSITIONED WITHIN THE ANNULUS IN A 50:50 POSITION. ECHO REVEALED MILD PARAVALVULAR LEAK AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THIS PATIENT¿S NATIVE VALVE, LEAFLET, AORTIC ROOT AND MITRAL ANNULAR CALCIFICATION WAS MILD. THERE WAS MILD VENTRICULAR SEPTAL HYPERTROPHY. THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WERE DESCRIBED AS GOOD. THERE WAS NO LOSS OF PACING CAPTURE DURING DEPLOYMENT AND VENTILATION WAS HELD. THE PATIENT¿S EJECTION FRACTION WAS 70 PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291532 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention