BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM

    MDR report key: 8884115 · Received August 12, 2019

    Report

    Report Number
    2015691-2019-02991
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 29, 2019
    Report Date
    July 29, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL POTENTIAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO A REPORT OF A RESTRICTED OR NON-FUNCTIONING LEAFLET. BASED ON HISTORICAL REVIEW OF COMPLAINTS, THESE EVENTS ARE TYPICALLY A RESULT OF TOO VENTRICULAR DEPLOYMENT OF THE VALVE IN COMBINATION WITH NATIVE LEAFLET OVERHANG. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE: LEAFLET IMPINGEMENT IN A HIGHLY CALCIFIED NATIVE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OR SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. THIS CAN RESULT IN A TEMPORARY DECREASE IN THE PRESSURE GRADIENT BETWEEN THE VENTRICLE AND THE AORTA, RESULTING IN AN INADEQUATE PRESSURE CHANGE TO CLOSE THE LEAFLETS. IN MANY INSTANCES THIS CAN BE OVERCOME WITH TROUBLE SHOOTING, WHICH INCLUDES BLOOD PRESSURE RECOVERY OR SUPPORT. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED. PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TAVR PROCEDURE.  REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, LEAFLET THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. IN THIS CASE, THE CAUSE FOR THE MODERATE TO SEVERE CENTRAL AORTIC INSUFFICIENCY AND THE RESTRICTED LEAFLET AT 6 YEARS AND 2 MONTHS POST IMPLANTATION CANNOT BE DETERMINED; HOWEVER, IT POSSIBLE THAT IT MAY BE RELATED TO THE PATIENT¿S COMORBIDITIES (CAD, HLN AND PRE-EXISTING VALVULAR DISEASE) AND/OR THE MECHANISMS DESCRIBED ABOVE. THERE WAS NO INDICATION A PRODUCT DEFICIENCY CONTRIBUTED TO THIS ADVERSE EVENT.  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

    APPROXIMATELY 6 YEARS AND 2 MONTHS POST IMPLANTATION OF A 26MM SAPIEN VALVE, AN ECHO (TEE) REVEALED THE LEFT LEAFLET TO BE RESTRICTED RESULTING IN MODERATE TO SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI). A DECISION WAS MADE TO DEPLOY A 2ND 26MM SAPIEN 3 VALVE. THE PROCEDURE WENT WELL. OF LAST COMMUNICATION, THE PATIENT WAS DISCHARGED APPROXIMATELY 1-DAY POST PROCEDURE. UPON REVIEW OF MEDICAL RECORDS, DURING EVALUATION THE PATIENT PRESENTED WITH PROGRESSIVE WORSENING OF FATIGUE FOR THE LAST YEAR. THE PATIENT HAS HAD PERIODIC ECHOES SINCE HIS PROCEDURE APPROXIMATELY 6 YEARS AGO. AFTER THE TAVR PROCEDURE THERE HAS BEEN PROGRESSION OF AORTIC REGURGITATION AND AN ECHO (TEE) REVEALED MODERATE TO SEVERE VALVULAR AORTIC REGURGITATION. AN ECHO PERFORMED TO EVALUATE PATIENT REVEALED A SAPIEN TAVR IN THE AORTIC POSITION, THERE IS NO SIGNIFICANT AORTIC STENOSIS; HOWEVER, THE LEFT LEAFLET IS SOMEWHAT RESTRICTED RESULTING IN MODERATE-SEVERE VALVULAR AORTIC INSUFFICIENCY. AN ECHO AT 1-DAY POST VALVE-IN-VALVE NOTED A WELL-SEATED AORTIC VALVE-IN-VALVE AND IS NOT SIGNIFICANTLY STENOTIC OR REGURGITANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676235 EDWARDS SAPIEN TRANSCATHETER HEART VALVE, 26MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention