BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3771606 · Received April 24, 2014

    Report

    Report Number
    2015691-2014-00944
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAPIEN INSTRUCTIONS FOR USE (IFU) INCLUDE A WARNING THAT INCORRECT SIZING OF THE BIOPROSTHESIS MAY LEAD TO PARAVALVULAR LEAK, MIGRATION, EMBOLIZATION AND/OR ANNULAR RUPTURE. ADDITIONAL POTENTIAL RISKS SPECIFICALLY ASSOCIATED WITH THE USE OF THE BIOPROSTHESIS INCLUDE VALVE DEPLOYMENT IN AN UNINTENDED LOCATION. THERE MAY BE CASES IN WHICH THE VALVE IS NOT ABLE TO BE DEPLOYED AT THE INTENDED LOCATION FOR VARIOUS REASONS. THIS MAY REQUIRE DEPLOYING THE VALVE AT A NON-TARGET LOCATION, TYPICALLY IN THE DESCENDING AORTA. ALTHOUGH, GENERALLY WELL TOLERATED, THE LONG TERM EFFECTS ARE NOT COMPLETELY UNDERSTOOD. IN THIS CASE, IT WAS DETERMINED THAT THE VALVE WAS 20% UNDERSIZED AFTER IT WAS INTRODUCED INTO THE BODY AND THAT DEPLOYMENT IN THE AORTIC ANNULUS WOULD NOT BENEFIT THE PATIENT. THUS, THE VALVE WAS DEPLOYED IN THE INFRARENAL SEGMENT OF THE ABDOMINAL AORTA AND THE PATIENT WAS SENT FOR SURGICAL AVR. NO DEVICE MALFUNCTION IS IDENTIFIED IN THE REPORT. 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. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO. 2015691-2014-00930.

    Description of Event or Problem · 1

    DURING A TRANSFEMORAL TAVR PROCEDURE THE 26MM SAPIEN VALVE WAS DEPLOYED IN A TOO AORTIC POSITION [80:20] CAUSING MODERATE PARAVALVULAR LEAK AND CENTRAL AORTIC INSUFFICIENCY. A SECOND VALVE WAS PREPPED, WHILE THE FIRST VALVE WAS BEING CROSSED BY THE SECOND VALVE, THE FIRST VALVE EMBOLIZED INTO THE LVOT. THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY, THE SECOND VALVE WAS DEPLOYED IN THE INFRA-RENAL PORTION OF THE ABDOMINAL AORTA, THE EMBOLIZED VALVE WAS REMOVED AND THE PATIENT RECEIVED A SURGICAL VALVE. PER ADDITIONAL INFORMATION RECEIVED THIS PATIENT SURVIVED THE SURGICAL PROCEDURE BUT EXPIRED LATER. THE IMPLANTING PHYSICIAN BELIEVES THE PATIENT¿S CORONARY STENTS MAY HAVE THROMBOSED CAUSING CARDIOVASCULAR COLLAPSE AND DEATH. PER REPORT, THE PATIENT¿S ANNULUS MEASUREMENT ON CT WAS 600-650, BUT HIS PRE-OP 3D TEE WAS 480 MM2. THE INTRA-OP TEE ANNULUS 474 3D, 24.7 BY 2D LV LONG AXIS. THE RIGHT FEMORAL ARTERY WAS ACCESSED AND THE RETROFLEX 3 SHEATH WAS INTRODUCED WITHOUT DIFFICULTY. BAV PERFORMED WITH A 22X4CM TRUE BALLOON WITH ROOT INJECTION. THE 26MM VALVE WAS DEPLOYED WITHIN THE ANNULUS IN A STABLE POSITION, THERE WAS MODERATE CENTRAL AORTIC INSUFFICIENCY AND MODERATE PARAVALVULAR LEAK; AO PRESSURE 120/45MMHG. THE VALVE WAS POST DILATED BUT THE PARAVALVULAR LEAK AND CENTRAL AORTIC INSUFFICIENCY DID NOT IMPROVE. A SECOND 26 VALVE WAS PREPPED/LOADED AND WHILE ATTEMPTING TO CROSS THE 1ST VALVE, THE 1ST VALVE DISLODGED INTO THE LEFT VENTRICLE IN A STABLE POSITION ON THE WIRE; THE PATIENT WAS STABLE. IT WAS NOTED THAT THE SECOND CRIMPED VALVE WAS TRACKING SUPERIORLY AND APPEARED TO BE RUBBING UP AGAINST THE FIRST VALVE. THE FIRST VALVE [EMBOLIZED] WAS STABLE IN THE LVOT AT THE LEVEL OF THE ANTERIOR MITRAL LEAFLET HINGE POINT. THE PATIENT WAS REMARKABLY STABLE AT THIS POINT (96/34MMHG). THE PHYSICIAN ATTEMPTED TO PULL BACK THE FIRST VALVE WITH A BALLOON. THE 6FR LEFT FEMORAL ARTERY SHEATH WAS EXCHANGED FOR A 14FR SHEATH, A 28X4 BALLOON WAS PREPPED AND CROSSED THE DISLODGED VALVE AND PULLED BACK INTO THE LVOT, HOWEVER THE POSITION OBSCURED THE MITRAL VALVE CAUSING MODERATE TO SEVERE MITRAL REGURGITATION. THE DECISION WAS MADE TO TRANSFER THE PATIENT TO THE OR. THE SECOND 26MM VALVE WAS DEPLOYED IN THE INFRA-RENAL SEGMENT OF THE ABDOMINAL AORTA, AS IT WAS THEN CONSIDERED UNDERSIZED FOR THE ANNULUS. THE SECOND VALVE WAS IN A STABLE POSITION AND THE DELIVERY SYSTEM WAS REMOVED AND THE ACCESS SITE WAS CLOSED VIA PERCLOSE. THE WIRE WAS INADVERTENTLY REMOVED, THE 1ST VALVE DISLODGED AGAIN AND WAS FREE FLOATING IN THE LEFT VENTRICLE. THE VALVE WAS REMOVED AND A SURGICAL VALVE WAS IMPLANTED. THE VALVE EMBOLIZATION WAS ATTRIBUTED TO THE ANNULUS BEING TOO LARGE FOR THE 26MM VALVE. THIS IS ONE OF TWO REPORTS BEING SUBMITTED FOR THIS CASE. THIS REPORT IS FOR THE SECOND VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250263 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention RETROFLEX 3 DELIVERY SYSTEM