BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN 3 VALVE

    MDR report key: 12675009 · Received October 21, 2021

    Report

    Report Number
    2015691-2021-05845
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 23, 2021
    Report Date
    December 9, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103194357
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THIS REPORT REPRESENTS THE SECOND IMPLANTED VALVE. PLEASE REFERENCE RELATED MANUFACTURER REPORT 2015691-2021- 06605. DEVICE DEGENERATION IS A KNOWN POTENTIAL RISK ASSOCIATED WITH THE TAVR PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT. STRUCTURAL VALVE DETERIORATION (SVD) MAY BE MANIFESTED AS STENOSIS WITH THICKENED LEAFLETS. SVD REFERS TO CHANGES INTRINSIC TO THE VALVE, AND CAN INCLUDE FAILURE MODES SUCH AS WEAR, CALCIFICATION, LEAFLET TEAR, STENT CREEP, LEAFLET DISRUPTION, OR LEAFLET RETRACTION. SVD MAY BE MILD AND NOT REQUIRE ANY INTERVENTION OR IT MAY BE MODERATE TO SEVERE. IT CAN CAUSE THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE. DEPENDING ON THE SEVERITY IT COULD BE AN INDICATION FOR VALVE REPLACEMENT OR MEDICAL INTERVENTION. TISSUE CALCIFICATION IS A VERY COMMON FAILURE MODE. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. IN THIS CASE, COMPLAINT WAS UNABLE TO BE CONFIRMED DUE TO DEVICE UNAVAILABILITY/IMAGERY UNAVAILABILITY. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE FOR THE VALVE DEGENERATION APPROXIMATELY 5 YEARS POST VALVE IMPLANT COULD NOT BE DETERMINED, BUT MAY BE RELATED TO THE PATIENTS COMORBIDITIES AND/OR PROGRESSION OF THE PREEXISTING VALVULAR DISEASE PROCESS. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. SECTION A2 WAS UPDATED. PER REVIEW OF IMAGERY BY AN EDWARDS PHYSICIAN PROCTOR, THE PATIENT WAS FOUND TO HAVE A STENOTIC TAVR VALVE. THE CORONARIES WERE FOUND TO BE ABOVE THE RISK PLANE. IT IS THEREFORE IMPORTANT NOT TO PLACE THE VALVE HIGHER THAN THE OLD VALVE. IT WAS SUGGESTED TO PLACE A 23MM VALVE PLUS 2CC. A 23MM SAPIEN 3 ULTRA VALVE WAS IMPLANTED WITHIN THE PREEXISTING SAPIEN 3 VALVE USING AN ADDITIONAL 2CC OF INFLATION VOLUME. POST PROCEDURE, THE PATIENT HAD A STROKE. THERE WAS A COMPLETE OCCLUSION OF THE RIGHT MCA. THE PATIENT WAS TREATED IN RADIOLOGY FOR EMBOLECTOMY. A LARGE EMBOLI WAS REMOVED AND FLOW WAS RESTORED. THE PHYSICIAN THOUGHT IT WAS POSSIBLE SOMETHING BROKE LOOSE OFF THE VALVE UPON VALVE DELIVERY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    APPROXIMATELY 5 YEARS POST IMPLANT OF A 26MM SAPIEN 3 VALVE IN THE AORTIC POSITION, THE VALVE FAILED FOR DEGENERATION BASED ON TEE IMAGES. THE PATIENT IS SYMPTOMATIC, BUT WAS NOT HOSPITALIZED FOR SYMPTOMS. A VALVE IN VALVE PROCEDURE WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574069 SAPIEN 3 VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26A NA 00690103194357

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Other