BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEAR VALVE

    MDR report key: 2438847 · Received February 3, 2012

    Report

    Report Number
    2015691-2012-16829
    Event Type
    Death
    Date Received
    February 3, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING REVIEW. ECHO IMAGES WERE SUBMITTED TO EDWARDS FOR REVIEW. THE FOLLOWING OBSERVATIONS WERE MADE BY EDWARDS MEDICAL STAFF: MEASUREMENTS: ASCENDING AORTA 34.9MM, STJ 29.2MM, SOV 29.2MM, ANNULUS 24.5MM = 4.7MM DIFFERENCE WHICH LEADS TO RESULT OF OBLITERATION OF SINUSES. MODERATE - SEVERE AORTIC CALCIFICATION, SEVERE ROOT CALCIFICATION. TEE OF BAV, VALVE POSITIONING, AND DEPLOYMENT NOT AVAILABLE FOR REVIEW. POST SAPIEN DEPLOYMENT IMAGES SHOW AN INTIMAL FLAP IN THE REGION OF THE RCC AS WELL AS THE PRESENCE OF A FALSE LUMEN IN THE POSTERIOR WALL. IMPRESSIONS: ACUTE AORTIC DISSECTION BEGINNING AT THE LEVEL OF THE RCC AND SPIRALING TO POSTERIOR WALL OF THE AORTA. CONTRIBUTING FACTORS TO THIS EVENT ARE SEVERE CALCIFICATION OF AORTIC ROOT AND OBLITERATION OF THE SOV. PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON AORTIC VALVULOPLASTY (BAV), ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES INCLUDE BUT ARE NOT LIMITED TO CARDIOVASCULAR INJURY INCLUDING PERFORATION OR DISSECTION OF VESSELS, WHICH MAY REQUIRE INTERVENTION. THE EXACT CAUSE FOR THE REPORTED DELAYED VASCULAR COMPLICATION CANNOT BE CONFIRMED. THERE WERE NO PROCEDURAL COMPLICATIONS OR DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. ACCORDING TO THE THV TRAINING MANUAL, RISK FACTORS FOR ACUTE AORTIC RUPTURE/ DISSECTION IN THE TAVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVERSIZING (I.E. =4MM) IN THE PRESENCE OF SEVERELY CALCIFIED AORTIC ROOT AND OBLITERATED SINUSES. IN THIS CASE, THE VALVE WAS NOT OVERSIZED AS A 26MM SAPIEN VALVE WAS IMPLANTED IN A 24.5MM NATIVE ANNULUS, HOWEVER, THE SINUSES WERE OBLITERATED AND THE AORTIC CUSPS WERE SEVERELY CALCIFIED. THE SEVERE CALCIFICATION OF AORTIC ROOT AND OBLITERATION OF THE SOV MOST LIKELY CONTRIBUTED TO THIS EVENT. ACCORDING TO THE EDWARDS SAPIEN SCREENING MANUAL, 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 EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE AND PROCEDURAL SUCCESS. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED FROM THE PATIENT; HOWEVER, PER REPORT, THERE WAS NO DEVICE MALFUNCTION. A DEVICE HISTORY REVIEW (DHR) FOR THE VALVE WAS PERFORMED AND ALL MANUFACTURERS SPECIFICATIONS WERE MET PRIOR TO RELEASE FOR DISTRIBUTION.INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSCATHETER HEART VALVE PROCEDURE, AN ASCENDING AORTIC DISSECTION WAS NOTED POST VALVE DEPLOYMENT. WITHIN 24 HOURS THE PATIENT SUFFERED A CARDIAC ARREST AND EXPIRED. INTRAPROCEDURAL TEE MEASURED THE AORTIC ANNULUS 24.4MM, STJ 27MM. ACCESS OBTAINED TO LFA, DILATORS AND SHEATH ADVANCED WITHOUT DIFFICULTY. 18X4 MAXI BALLOON USED FOR BAV PERFORMED UNDER RVP, UPON FIRST INFLATION THE BALLOON SLIPPED VENTRICULAR. THE PHYSICIAN WAS CONCERNED ABOUT BEING ABLE TO CROSS THE ANNULUS WITH THE RF3 BECAUSE OF HEAVY CALCIFIED LEAFLETS SO THE BAV WAS REPEATED A TOTAL OF 5 TIMES. RF3 ADVANCED WITHOUT DIFFICULTY TO THE ANNULUS. THERE WERE MULTIPLE ATTEMPTS CROSSING AND RE-CROSSING THE VALVE DUE TO THE SYSTEM SLIPPING INTO THE VENTRICLE OR INTO THE AORTA. THE PHYSICIANS NOTED EXCESSIVE TENSION AND FORCE NECESSARY TO POSITION AND REPOSITION THE SYSTEM WITHIN THE ANNULUS. ECHO AND AORTOGRAMS WERE UTILIZED FOR FINAL POSITIONING AND THE VALVE WAS DEPLOYED 60:40. THERE WAS WIRE RELATED CAI AND ZERO PVL ON ECHO HOWEVER AN AORTIC FLAP WAS NOTED. AT THIS TIME, ECHO CONFIRMED THERE WAS A SMALL PERICARDIAL EFFUSION WHICH WOULD BE REASSESSED IN SEVERAL MINUTES FOR ANY CHANGE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY AND ATTENTION WAS TURNED BACK TO THE AORTA AND AN AORTIC ROOT SHOT WAS TAKEN. A LARGE AORTIC DISSECTION WAS NOTED FROM JUST ABOVE THE RCA UP THROUGH THE AORTIC ARCH. SYSTOLIC BP WAS STABLE ON PRESSORS IN THE 80-90S AND THE PHYSICIANS TOOK TIME TO DISCUSS OPTIONS. IT WAS DECIDED THAT THE RISK OF SURGERY WAS TOO HIGH DUE TO PATIENT HISTORY (AGE, PREDNISONE USE AND POOR LUNG FUNCTION), THIS BEING A TRAUMATIC DISSECTION AND NOT SPONTANEOUS LEAVING MEDICAL MANAGEMENT AS THE PATIENTS BEST CHANCE FOR SURVIVAL. DURING THIS TIME, ECHO ASSESSED THE PERICARDIAL EFFUSION AND REPORTED NO CHANGE. THE SHEATH WAS REMOVED AND VESSELS WERE VISUALIZED WITHOUT COMPLICATIONS. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO ICU WHERE HE WAS TO BE CLOSELY MONITORED TO KEEP SBP <100 AND NO ANTICOAGULATION. THE PATIENT'S CONDITION WORSENED, HE SUFFERED CARDIAC ARREST AND EXPIRED WITHIN 24 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEAR VALVE REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26 59084438

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R