BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 12380869 · Received August 27, 2021

    Report

    Report Number
    2015691-2021-04897
    Event Type
    Death
    Date Received
    August 27, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 27, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OR ALLEGATION OF AN EDWARDS DEVICE MALFUNCTION AND THE DEVICE WAS DISCARDED. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA OR ANNULAR RUPTURE DURING THE TAVR PROCEDURE INCLUDE SIGNIFICANT THV OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED STJ. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS INDICATE PER MEDICAL OPINION, THE ROOT CAUSE OF THE ANNULAR RUPTURE MAY HAVE BEEN THE EXCESSIVE LVOT CALCIFICATION OR POSSIBLY OVERSIZING OF THE THV VALVE DUE TO CONFLICTING MEASUREMENTS PRE-TAVR. THE CAUSE OF DEATH WAS UNSALVAGEABLE SUBANNULAR/LVOT RUPTURE. 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 MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. DEVICE DISCARDED.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), THE PATIENT WHO UNDERWENT AN IMPLANT OF A 26MM SAPIEN XT VALVE, IN AORTIC POSITION BY TRANSFEMORAL APPROACH. AS REPORTED, DUE TO DIFFERENCES IN MEASUREMENT BETWEEN CT/3MENSIO, ANGIO AND ECHO, VALVE IMPLANT SIZE WAS NOT COMPLETELY CLEAR. FINALLY, A 26MM SAPIEN 3 XT - 1 ML WAS DETERMINED TO BE THE BEST OPTION. A VALVULOPLASTY WAS PERFORMED TO CONFIRM THE CORRECT SIZE. THE VALVE WAS PREPARED WITH A 26 MM VOL - 1 ML, SO A 21 MM VOLUME WAS FILLED IN THE ATRIA. THE DELIVERY SYSTEM WAS INSERTED, EVERYTHING SEEMED TO GO WELL, AND THE VALVE WAS DEPLOYED SLOWLY. NO PVL WAS NOTED, BUT THE PATIENT' S BLOOD PRESSURE WENT UP DRASTICALLY. A CARDIAC TAMPONADE WAS OBSERVED AND A PERI CARDIOCENTESIS WAS PERFORMED. AN ANNULAR RUPTURE WAS DIAGNOSED ON IMAGING. THE PATIENT WAS TAKEN TO EMERGENCY SURGERY FOR REPAIR. THE RUPTURE WAS SUBANNULAR/LVOT. THE PATIENT WAS ON BYPASS FOR AN HOUR BUT, UNFORTUNATELY, PASSED AWAY ON THE TABLE. AS PER MEDICAL OPINION, THE ROOT CAUSE OF THE ANNULAR RUPTURE MAY HAVE BEEN THE EXCESSIVE LVOT CALCIFICATION. THE CAUSE OF DEATH WAS UNSALVAGEABLE SUBANNULAR/LVOT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273933 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26 6811135

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R