BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8404740 · Received March 8, 2019

    Report

    Report Number
    2015691-2019-00788
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    February 15, 2012
    Report Date
    February 14, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE MFG. REPORT NUMBERS 2015691-2019-00799 AND 2015691-2019-00800.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031. PER THE INSTRUCTIONS FOR USE (IFU), THROMBUS FORMATION, PLAQUE DISLODGEMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION (MI) ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TAVR PROCEDURE. THE IFU CAUTIONS THAT THE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS IN CLOSE PROXIMITY TO THE CORONARY OSTIA. IN ADDITION, CAUTION SHOULD BE EXERCISED WHEN IMPLANTING A BIOPROSTHESIS IN PATIENTS WITH CLINICALLY SIGNIFICANT CORONARY ARTERY DISEASE. MI RELATED TO THE TAVR PROCEDURE AND THE VALVE IMPLANT WILL MANIFEST INTRA-PROCEDURALLY OR IN THE IMMEDIATE POST-OPERATIVE PERIOD, AND IS TYPICALLY DUE TO A COMBINATION OF PATIENT AND/OR PROCEDURAL FACTORS. AS DEFINED IN THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) PUBLICATION ON TAVR COMPLICATIONS, THE PERI-PROCEDURAL INTERVAL IS INCLUSIVE OF ALL EVENTS THAT BEGIN WITHIN 72 HRS OF THE INDEX PROCEDURE. MI¿S THAT OCCUR AFTER THE PERI-PROCEDURAL PERIOD (>72HRS) ARE TYPICALLY RELATED TO THE PATIENT¿S UNDERLYING CORONARY DISEASE. THERE ARE MULTIPLE PATIENT FACTORS THAT COULD PUT THE PATIENT AT RISK FOR MI DURING THE TAVR PROCEDURE, INCLUDING SIGNIFICANT UNDERLYING CORONARY ARTERY DISEASE, AND BULKY CALCIFICATION OF THE NATIVE LEAFLETS AND ROOT. DISPLACEMENT OF CALCIUM DEPOSITS WITH EMBOLIZATION OF DEBRIS INTO ONE OF THE ARTERIES, OR AORTIC DISSECTION WITH CONTINUITY OF THE RUPTURE INTO THE INTIMA OF ONE OF THE CORONARY OSTIA, CAN RESULT IN THIS COMPLICATION. THE EDWARDS THV MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. IN THIS CASE, THE CAUSE OF THE MYOCARDIAL INFARCTION IS UNKNOWN; HOWEVER, IT MAY BE RELATED TO PATIENT/PROCEDURAL FACTORS THAT WERE NOT PROVIDED IN THE ARTICLE. THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. 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. BIBLIOGRAPHY: MOHAMMED A. AL-HIJJI, M. C. (2019). LEFT VENTRICULAR REMODELING AND FUNCTION AFTER TRANSAPICAL VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT. CATHETERIZATION, CARDIOVASCULAR INTERVENTION, 1-7.

    Description of Event or Problem · 1

    A SINGLE-CENTER RETROSPECTIVE STUDY OF ALL TAVR PERFORMED FROM FEBRUARY 2012 TO JUNE 2016 WAS PUBLISHED IN THE JOURNAL ARTICLE ¿LEFT VENTRICULAR REMODELING AND FUNCTION AFTER TRANSAPICAL VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT". THREE HUNDRED AND FIFTY-NINE PATIENTS UNDERWENT BALLOON-EXPANDABLE TAVR USING SAPIEN VALVES WERE INCLUDED. THESE CASES WERE BOTH TRANSAPICAL AND TRANSFEMORAL. ONE HUNDRED AND FIFTEEN PATIENTS WHO UNDERWENT TA TAVR (TA GROUP) WERE COMPARED TO 115 PROPENSITY MATCHED PATIENTS WHO UNDERGONE TF TAVR (TF GROUP). THIS REPORT IS FOR 2 PATIENTS WHO EXPERIENCED A MYOCARDIAL INFARCTION (TA) POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196518 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other