BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN VALVE UNKNOWN

    MDR report key: 15890740 · Received November 30, 2022

    Report

    Report Number
    2015691-2022-09576
    Event Type
    Death
    Date Received
    November 30, 2022
    Date of Event
    January 1, 2012
    Report Date
    January 13, 2023
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. ARTICLE REFERENCE: YUN, JAMES J., ET AL. CARDIAC OPERATIONS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. THE ANNALS OF THORACIC SURGERY 114.1 (2022): 52 TO 59. IT WAS UNKNOWN WHICH VALVE THE PATIENTS RECEIVED SAPIEN, SAPIEN XT OR SAPIEN 3 VALVES. THE PMA NUMBERS ARE P110021, P130009 AND P140031, RESPECTIVELY. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM JANUARY 2012 THROUGH JULY 2020. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01 JAN 2012) WAS USED AS THE OCCURRENCE DATE. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES, AND HEMATOMA ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL THV PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE THV TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, HEMATOMA, OR ANNULAR RUPTURE DURING THE THV 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 PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE AORTIC DISSECTION COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE AUTHORS. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    FROM JANUARY 2012 THROUGH JULY 2020, 30 PATIENTS WITH SAPIEN TAVR VALVES UNDERWENT POST TAVR CARDIAC SURGERY AT CLEVELAND CLINIC. OF THESE 30, 4 PATIENTS HAD SAPIEN VALVES, 4 PATIENTS HAD SAPIEN XT VALVES, AND 22 HAD SAPIEN 3 VALVES. PER THE ARTICLE, ONE PATIENT UNDERWENT POST TAVR CARDIAC SURGERY. THE PATIENT HAD A TEAR IN THE AORTIC ARCH REQUIRING ASCENDING AORTA DISSECTION REPAIR AND ECMO. THE PATIENT EXPIRED DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2712865 SAPIEN VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC SAPIEN VALVE UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R