BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 9679528 · Received February 6, 2020

    Report

    Report Number
    2015691-2020-10411
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    November 1, 2019
    Report Date
    January 13, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    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 YET 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, THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE. AS LIMITED INFORMATION WAS PROVIDED, THERE ARE NO KNOWN RISK FACTORS THAT COULD HAVE CONTRIBUTED TO THE EVENT (END-STAGE RENAL INSUFFICIENCY, DISORDER OF CALCIUM METABOLISM). THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. 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. REFERENCE MFG. REPORT NO. 2015691-2020-10409 BIBLIOGRAPHY: HYUN JUNG KOO, M. P.-Y. (2019). COMPUTED TOMOGRAPHY FEATURES OF CUSPAL THROMBOSIS AND SUBVALVULAR TISSUE INGROWTH AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. THE AMERICAN JOURNAL OF CARDIOLOGY.

    Description of Event or Problem · 1

    A RETROSPECTIVE STUDY WAS PUBLISHED IN (B)(6) IN A JOURNAL ARTICLE ¿COMPUTED TOMOGRAPHY FEATURES OF CUSPAL THROMBOSIS AND SUBVALVULAR TISSUE INGROWTH AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION.¿ THE STUDY WAS FROM MARCH 2011 AND DECEMBER 2017 AND INCLUDED 70 PATIENTS WHO UNDERWENT TAVI WITH AN EDWARDS SAPIEN VALVE (SAPIEN, N = 3; SAPIEN XT N = 56; AND SAPIEN 3, N = 11) AND HAD POST-TAVI CT SCANS. THE PATIENTS RECEIVED ANTICOAGULATION/ANTIPLATELET AFTER TAVI (ASPIRIN, CLOPIDOGREL, WARFARIN AND NOAC = NOVEL OR NON-VITAMIN K-DEPENDENT ANTAGONIST ORAL ANTICOAGULANT). CARDIAC CT SCANS WERE PERFORMED FROM 0 TO 2,624 DAYS AFTER TAVI. THE FOLLOWING EVENTS OCCURRED IN THE SAPIEN GROUP: ONE PATIENT WAS DIAGNOSED WITH PANNUS FORMATION AND SHOWED HAST (HYPOATTENUATING SUBVALVULAR THICKENING) WITH SEVERE LEAFLET MOTION LIMITATION INTRACTABLE WITH ANTICOAGULATION AFTER 2,624 DAYS FROM TAVI AND ACCOMPANIED BY HIGH PEAK VELOCITY AND PG. THIS PATIENT FINALLY UNDERWENT VALVE-IN-VALVE TAVI. A (B)(6)-YEAR-OLD WOMAN WHO UNDERWENT TAVI USING AN XT VALVE. 5.2 YEARS POST-TAVI, THE TRANSAORTIC PEAK VELOCITY AND PRESSURE GRADIENT SEEN ON ECHOCARDIOGRAPHY WERE HIGH (5.4 M/SEC AND 71 MM HG), EVEN THOUGH SHE WAS MANAGED WHILE HAVING INTENSE ANTICOAGULATION USING WARFARIN. POST-TAVI CT SHOWED EXTENSIVE SUB-VALVULAR (CALCIFICATIONS AND CIRCUMFERENTIAL SOFT TISSUE SURROUNDING THE INNER WALL OF THE TAVI DEVICE) AND LEAFLET THICKENING (CALCIFIED AORTIC CUSPS WITH NODULAR SOFT-TISSUE THICKENING WERE NOTED). THE PATIENT UNDERWENT REDO-SURGICAL AORTIC VALVE REPLACEMENT. SURGICALLY, FIBROTIC PANNUS FORMATION IN THE SUB-VALVULAR AREA WAS NOTED, AND A DEGENERATIVE AORTIC VALVE WITH SUPRAVALVULAR FIBROTIC TISSUE WAS ALSO DISCOVERED. AN (B)(6)-YEAR-OLD WOMAN UNDERWENT TAVI USING SAPIEN XT. TWO DAYS AFTER THE TAVI DATE, LOW ATTENUATION SOFT TISSUE WAS NOTED AT THE OUTSIDE OF THE TAVI DEVICE WITHIN THE RIGHT SINUS OF VALSALVA. THE LESION WAS PERSISTENTLY NOTED IN MULTIPHASE CT IMAGES, INCLUDING DIASTOLIC PHASE IMAGES. LOW ATTENUATION, PERI-STENT SOFT TISSUE WAS CONFINED TO THE RIGHT SINUS OF VALSALVA, AND THUS SUGGESTING THROMBUS WITHIN THE SINUS OF VALSALVA. IN 13 PATIENTS, HYPOATTENUATING LEAFLET THICKENING (HALT) WAS DETECTED AND LEAFLET MOTION LIMITATION WAS OBSERVED IN 11 PATIENTS. THIS COMPLAINT REPRESENTS A (B)(6)-YEAR-OLD PATIENT WHO UNDERWENT A TAVI OF A SAPIEN XT VALVE AND APPROXIMATELY 5.2 YEARS POST PROCEDURE THE TRANSAORTIC PEAK VELOCITY AND PRESSURE GRADIENT ON ECHO WERE HIGH (5.4 M/SEC AND 71MMHG, EVEN THOUGH THE PATIENT WAS MANAGED WHILE HAVING INTENSE ANTICOAGULATION. THE PATIENT UNDERWENT A RE-DO SURGICAL AORTIC VALVE REPLACEMENT. SURGICALLY, FIBROTIC PANNUS FORMATION IN THE SUB-VALVULAR AREA WERE NOTED, AND A DEGENERATIVE AORTIC VALVE WITH SUPRAVALVULAR FIBROTIC TISSUE WAS ALSO DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141791 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN XT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention