BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 UNKNOWN

    MDR report key: 11041749 · Received December 18, 2020

    Report

    Report Number
    2015691-2020-15120
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    March 1, 2016
    Report Date
    November 25, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NUMBER: 2015691-2020-15117, 2015691-2020-15120, 2015691-2020-15122, 2015691-2020-15124, 2015691-2020-15128, 2015691-2020-15129, 2015691-2020-15130.

    Additional Manufacturer Narrative · 1

    THE DATES OF THE EVENTS ARE UNKNOWN. THEREFORE, THE FIRST DAY OF THE DATE RANGE OF THE EVENT WAS USED AS THE OCCURRENCE DATE. ARTICLE REFERENCE: KOOISTRA, NYNKE H., VALENT MP INTAN-GOEY, FRANCESCA ZIVIELLO, GEERT E. LEENDERS, ADRIAAN O. KRAAIJEVELD, PIETER A. DOEVENDANS, NICOLAS M. VAN MIEGHEM, MICHIEL VOSKUIL, AND PIETER R. STELLA. "COMPARISON OF THE SAPIEN 3 VERSUS THE ACURATE NEO VALVE SYSTEM: A PROPENSITY SCORE ANALYSIS." CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2020). PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE REGURGITATION INCLUDING, BUT NOT LIMITED TO, MALPOSITION OF THE VALVE, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, A SEVERELY ELLIPTICAL ANNULUS SHAPE, VALVE UNDER-SIZING. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE FOR THE REGURGITATION COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED BY THE AUTHORS. 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.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN NETHERLANDS, PER THE MEDICAL ARTICLE, ¿COMPARISON OF THE SAPIEN 3 VERSUS THE ACCURATE NEO VALVE SYSTEM: A PROPENSITY SCORE ANALYSIS¿, A RETROSPECTIVE STUDY OF 230 PATIENTS WITH SYMPTOMATIC, SEVERE AORTIC STENOSIS THAT RECEIVED A SAPIEN 3 VALVE AT TWO DUTCH CENTERS BETWEEN MARCH 2016 AND NOVEMBER 2018 WAS PERFORMED. DURING THE STUDY PERIOD, 2 PATIENTS HAD MODERATE OR SEVERE PROSTHETIC VALVE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502599 SAPIEN 3 UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other