BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPIEN VALVE UNKNOWN

    MDR report key: 21240384 · Received January 27, 2025

    Report

    Report Number
    2015691-2025-00478
    Event Type
    Death
    Date Received
    January 27, 2025
    Date of Event
    January 1, 2015
    Report Date
    January 27, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE REPORTS BEING SUBMITTED FOR THIS CASE. ARTICLE CITATION: RINGS L, MAVROVA-RISTESKA L, HAEUSSLER A ET AL. LACTATE DEHYDROGENASE LEVELS AFTER AORTIC VALVE REPLACEMENT: WHAT DO THEY TELL US?. THE THORACIC AND CARDIOVASCULAR SURGEON 2024. DOI: 10.1055/A-2454-9020. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS SAPIEN TRANSCATHETER HEART VALVE ARE: P110021- EDWARDS SAPIEN TRANSCATHETER HEART VALVE; P130009 - EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE; P140031- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AND EDWARDS SAPIEN 3 ULTRA HEART VALVE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE PROVIDED THE FOLLOWING DATE RANGE ON PAGE 3: "(FROM JAN 2015 UNTIL DEC 2018)." THEREFORE, 01JAN2015 WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING HEMATOMA, PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, ATRIUM, SEPTUM, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE DEVICE TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, CARDIAC/AORTIC HEMATOMA, OR ANNULAR RUPTURE DURING THE TVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION, AND NARROW CALCIFIED SINOTUBULAR JUNCTION. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN TRANSCATHETER HEART VALVE (ALL MODELS) RELIES CALCIUM TO SECURELY ANCHOR IN THE LANDING ZONE. 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. INVESTIGATION RESULTS ARE INCONCLUSIVE AS SPECIFIC PATIENT AND PROCEDURAL FACTORS WERE NOT PROVIDED; HOWEVER, THE EVENT COULD BE RELATED TO THE MECHANISMS DESCRIBED ABOVE. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED IN MEDICAL ARTICLE "LACTATE DEHYDROGENASE LEVELS AFTER AORTIC VALVE REPLACEMENT: WHAT DO THEY TELL US?", A PATIENT UNDERWENT A TRANSAPICAL TAVI PROCEDURE WITH AN UNKNOWN SAPIEN VALVE IMPLANTED IN AORTIC POSITION. THE PATIENT HAD AN ANNULAR RUPTURE RESULTING IN A VENTRICULAR SEPTAL DEFECT AND RUPTURE OF THE PAPILLARY MUSCLE WITH A CONSECUTIVE FLAIL OF THE MITRAL ANTERIOR LEAFLET RESULTING IN SEVERE INSUFFICIENCY. AFTER CARDIOPULMONARY BYPASS STABILIZATION AND EXTUBATION, THE PATIENT DECIDED NOT TO UNDERGO ANOTHER INTERVENTION AND PASSED AWAY ON POSTOPERATIVE DAY 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830388 SAPIEN VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R