BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 17175411 · Received June 21, 2023

    Report

    Report Number
    2015691-2023-14080
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    August 1, 2015
    Report Date
    June 21, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ARTICLE OKAJIMA, KAZUE, IKKI KOMATSU, AND TODD B. SETO. LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3. INTERNATIONAL JOURNAL OF ANGIOLOGY 31.02 (2021): 120-125. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM AUGUST 2015 TO DECEMBER 2017. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-AUGUST 2015) WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES, ANNULAR TEAR, OR RUPTURE ARE KNOWN POTENTIAL RISKS OR 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 OVERSIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA, AND/OR PRESENCE OF BULKY CALCIFICATION AND NARROW CALCIFIED ST J. 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 CARDIOVASCULAR 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. PERICARDIAL EFFUSION IS AN ABNORMAL ACCUMULATION OF FLUID IN THE PERICARDIAL CAVITY. BECAUSE OF THE LIMITED AMOUNT OF SPACE IN THE PERICARDIAL CAVITY, FLUID ACCUMULATION WILL LEAD TO AN INCREASED INTRA PERICARDIAL PRESSURE WHICH CAN NEGATIVELY AFFECT HEART FUNCTION. WHEN THERE IS A PERICARDIA! EFFUSION WITH ENOUGH PRESSURE TO ADVERSELY AFFECT HEART FUNCTION, THIS IS CALLED CARDIAC TAMPONADE. IT CAN BE CAUSED BY A VARIETY OF LOCAL AND SYSTEMIC DISORDERS, OR IT MAY BE IDIOPATHIC. PERICARDIAL EFFUSIONS CAN BE ACUTE OR CHRONIC, AND THE TIME COURSE OF DEVELOPMENT HAS A SIGNIFICANT IMPACT ON THE PATIENT'S SYMPTOMS. IN THV PATIENTS, IT MAY BE CAUSED BY GUIDEWIRE PERFORATIONS OR ANNULAR RUPTURES. IN TRANSAPICAL PATIENTS, POSTOPERATIVE PERICARDIA! EFFUSIONS ARE COMMON, MOST WILL RESOLVE SPONTANEOUSLY, AND SOME MAY REQUIRE INTERVENTION. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE CAUSE OF THE EVENT IS UNKNOWN. 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, PER ARTICLE, "LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3'', THE STUDY INCLUDES A TOTAL OF 201 PATIENTS WHO WERE TREATED WITH SAPIEN 3 VALVE (SP3) FROM AUGUST 2015 TO DECEMBER 2017 AT THE QUEENS MEDICAL CENTER, HONOLULU, HI. THE STUDY INCLUDED 21 PATIENTS WITH 20MM SAPIEN 3 VALVES, 67 WITH 23MM SAPIENT 3 VALVES, AND 113 WITH 26 OR 29MM SAPIEN 3 VALVES. EVENTS WERE CAPTURED FROM TABLE 2 PROCEDURAL OUTCOMES AND TABLE 3 HEMODYNAMIC PARAMETERS (POSTPROCEDURAL). THIS EVENT IS FOR AFTER IMPLANTATION OF A 23MM SAPIEN 3 VALVE, 1 PATIENT HAD A CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421718 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other