BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2893905 · Received January 3, 2013

    Report

    Report Number
    2015691-2013-18995
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT HAS A MILDLY CALCIFIED AORTIC ROOT ALONG WITH MODERATELY CALCIFIED NATIVE LEAFLETS. IN ADDITION, SEVERE MITRAL ANNULAR CALCIFICATION (MAC) AND MILD SEPTAL HYPERTROPHY WERE ALSO NOTED. PRIOR TO DEPLOYMENT, THERE WAS GOOD IMAGE INTENSIFIER ANGLE AND COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM. THE VALVE WAS POSITIONED AND DEPLOYED IN A 60:40 VENTRICULAR POSITION 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)). ECHO AND CINE IMAGERY IS NOT AVAILABLE TO ASSESS THE CAUSE OF THE EVENT. INVESTIGATION TO DETERMINE A POSSIBLE CAUSE OF THE REPORTED EVENT IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, A 23MM SAPIEN VALVE WAS IMPLANTED WITHIN A 21MM AORTIC ANNULUS. THERE WAS NO SIGNIFICANT VALVE OVERSIZING THAT COULD CONTRIBUTE TO THE REPORTED EVENT. THE EXACT CAUSE OF THE REPORTED DISSECTION CANNOT BE CONFIRMED; HOWEVER IN ADDITION TO THE PROCEDURAL FACTORS ITSELF, IT WAS NOTED THAT THE PATIENT WAS NOTED TO HAVE MODERATELY CALCIFIED AORTIC ROOT, WHICH COULD HAVE CAUSED OR 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 EDWARDS SAPIEN VALVE, AT THE TIME OF VASCULAR CLOSURE OF THE ACCESS SITE, THE PATIENT'S BLOOD PRESSURE DROPPED. EXAMINATION OF THE VALVE VIA ECHO REVEALED A DISSECTION OF THE ASCENDING AORTA. THE OPERATING TEAM DID NOT PERFORM AN INTERVENTION AND THE PATIENT WAS MONITORED CLOSELY IN THE ICU. THE PATIENT WAS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3212 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention