BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2900583 · Received January 7, 2013

    Report

    Report Number
    2015691-2013-19028
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT HAS A MODERATELY CALCIFIED AORTIC ROOT ALONG WITH SEVERE CALCIFICATION OF THE NATIVE VALVE AND LEAFLETS. IN ADDITION, SEVERE MITRAL ANNULAR CALCIFICATION (MAC) AND MODERATE SEPTAL HYPERTROPHY WERE ALSO NOTED. PRIOR TO DEPLOYMENT, BOTH THE IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM WERE REPORTED TO BE GOOD. THE VALVE WAS POSITIONED AND DEPLOYED 50:50 WITHIN THE AORTIC ANNULUS. DURING DEPLOYMENT, VENTILATION WAS HELD AND THERE WAS NO LOSS OF PACING CAPTURE. ACCORDING TO THE IFU, CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE, BALLOON VALVULOPLASTY, AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. ANNULAR/AORTIC RUPTURE IS TYPICALLY A COMBINATION OF FACTORS, INCLUDING ANATOMIC FACTORS (SEVERELY CALCIFIED AORTIC ROOT. OBLITERATED SINUSES OF VALSALVA (SOV)), AND PROCEDURAL FACTORS (SIGNIFICANT VALVE OVERSIZING (=4MM)). IN THIS CASE, THE EXACT CAUSE OF THE REPORTED AORTIC PERFORATION CANNOT BE CONFIRMED; HOWEVER, IN ADDITION TO THE PROCEDURAL FACTORS ITSELF, THE PATIENT'S SEVERELY CALCIFIED LEAFLETS / NATIVE VALVE AND MAC COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IN ADDITION A 23MM SAPIEN VALVE WAS IMPLANTED WITHIN AN ANNULUS MEASURING 18.1MM (VIA TEE). ALL OF THESE FACTORS COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. 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 THE MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, POST DEPLOYMENT OF THE SAPIEN VALVE THE PATIENT WAS FOUND TO HAVE A PERFORATION OF THE AORTA. ACCORDING TO THE CASE SUMMARY, 25 MINUTES POST DEPLOYMENT OF THE SAPIEN VALVE, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND PRESSORS WERE NEEDED FOR SUPPORT. IT WAS DISCOVERED THAT AN EFFUSION WAS NOTED VIA ECHO (TEE). AN AORTOGRAM WAS PERFORMED AND A PERFORATION WAS NOTED IN THE AORTA. THE PHYSICIAN PROCEEDED TO OPEN THE CHEST TO REPAIR THE TEAR IN THE AORTA. THE PATIENT'S PRESSURE WAS NORMALIZED THE CHEST WAS CLOSED. IT WAS DISCUSSED THAT THE CAUSE OF THE PERFORATION WAS DUE TO A SMALL ANNULUS AND HEAVILY CALCIFIED LEAFLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6783 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59072548, 59260280

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR