BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8291055 · Received January 30, 2019

    Report

    Report Number
    2015691-2019-00312
    Event Type
    Injury
    Date Received
    January 30, 2019
    Report Date
    January 9, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    REFERENCE ARTICLE: BAGUR, RODRIGO, ÉRIC DUMONT, DANIEL DOYLE, ROBERT DE LAROCHELLIÈRE, AND JOSEP RODÉS-CABAU. "TRANSCATHETER AORTIC VALVE-IN-VALVE-IN-VALVE IMPLANTATION FOR A FAILED XENOGRAFT." THE ANNALS OF THORACIC SURGERY 93, NO. 2 (2012): 647-650. PER THE INSTRUCTIONS FOR USE (IFU), VALVE MIGRATION REQUIRING INTERVENTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT. ACCORDING TO LITERATURE REVIEW, VALVE MIGRATION RESULTS WHEN FORCES ACTING ON THE TRANSCATHETER HEART VALVE (THV) OVERCOME THE STRENGTH OF ATTACHMENT OF THE VALVE TO THE AORTIC WALL. STENT VALVES ARE SUBJECTED TO ANTEGRADE EJECTION FORCES DURING SYSTOLE. LESS-THAN-SEVERE AND NON-UNIFORMLY DISTRIBUTED CALCIFICATION OF THE NATIVE LEAFLETS, INCORRECT BIOPROSTHETIC VALVE SIZING, AND INCOMPLETE FRAME EXPANSION, CAN CONTRIBUTE TO VALVE MIGRATION. ADDITIONALLY, RESIDUAL OVERHANGING LEAFLETS CAN EXERT DOWNWARDS FORCE DURING DIASTOLE, CAUSING MIGRATION OF THE THV TOWARDS THE LEFT VENTRICLE. THE EDWARDS THV PATIENT SCREENING MANUAL ADVISES THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE AND ROOT, TAKING INTO CONSIDERATION THE DEGREE AND DISTRIBUTION OF NATIVE LEAFLET CALCIFICATION. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. 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. THE CORRECT SIZING, ALIGNMENT AND POSITIONING OF THE DEVICE ARE EMPHASIZED AS KEY FACTORS TO THE PLACEMENT AND FIXATION OF THE DEVICE. THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE SAPIEN VALVE IN A PREVIOUSLY IMPLANTED SURGICAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN VALVE IN THIS SCENARIO. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  THE CAUSE OF THE VALVE MIGRATION IS UNKNOWN, HOWEVER, PER THE AUTHOR, THE EDWARDS SAPIEN VALVE WAS IMPLANTED IN A PRE-EXISTING NON-EDWARDS SURGICAL VALVE, ¿THE RIGIDITY OF THE SURGICAL BIOPROSTHETIC RING CAN PRECLUDE FULL EXPANSION OF THE TAV AND LEAD TO PROSTHESIS¿PATIENT MISMATCH OR LEAFLET DISRUPTION¿. 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 AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), MEDICAL ARTICLE "TRANSCATHETER AORTIC VALVE-IN-VALVE-IN-VALVE IMPLANTATION FOR A FAILED XENOGRAFT" CORRESPONDING AUTHOR DR. JOSEP RODÉS-CABAU ET AL. WAS REVIEWED AND THE FOLLOWING EVENT WAS CAPTURED. A CASE OF A (B)(6) MULTI-MORBID MALE PATIENT WITH A PRIOR AORTIC VALVE REPLACEMENT (AVR) WITH A NON-EDWARDS VALVE, WAS ADMITTED WITH PULMONARY EDEMA DUE TO SEVERE XENOGRAFT STENOSIS AND WITH A VERY HIGH OPERATIVE RISK. A VALVE-IN-VALVE PROCEDURE WITH A 23 MM EDWARDS-SAPIEN VALVE IN AORTIC POSITION BY TRANSAPICAL APPROACH WAS PERFORMED 13 YEARS AFTER HIS FIRST AORTIC SURGICAL VALVE REPLACEMENT WITH A NON-EDWARDS VALVE. THE VALVE WAS POSITIONED WITH APPROXIMATELY HALF OF THE STENT BELOW AND HALF ABOVE THE AORTIC ANNULUS AS DETERMINED BY TEE AND ANGIOGRAPHY. IMMEDIATELY AFTER VALVE DEPLOYMENT, THE NEWLY IMPLANTED VALVE TENDED TO SHIFT TOWARD THE LEFT VENTRICLE, AND A SECOND 23 MM EDWARDS-SAPIEN VALVE WAS IMPLANTED WITHIN THE FIRST ONE¿A VINVINV IMPLANTATION TO ANCHOR THE FIRST TRANSCATHETER VALVE AND AVOID FURTHER VENTRICULAR EMBOLIZATION. ECHOCARDIOGRAPHY AT HOSPITAL DISCHARGE SHOWED A RESIDUAL MEAN TRANSVALVULAR GRADIENT OF 17 MM HG AND TRIVIAL PARAVALVULAR AORTIC REGURGITATION. AT 1 YEAR FOLLOW-UP, THE PATIENT WAS IN NYHA FUNCTIONAL CLASS II. ACCORDING TO THE AUTHORS¿ OPINION, THE RIGIDITY OF THE SURGICAL BIOPROSTHETIC RING CAN PRECLUDE FULL EXPANSION OF THE TAV AND LEAD TO PROSTHESIS¿PATIENT MISMATCH OR LEAFLET DISRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81268 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention