BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3171772 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20360
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRANSTHORACIC ECHO (TEE) PERFORMED ((B)(6) 2013) 2 MONTHS POST TAVR INDICATED THAT THE PEAK TRANSAORTIC VALVE GRADIENT WAS 73 MMHG WITH A MEAN GRADIENT OF 33 MMHG. THE PATIENT WAS PUT BACK ON PLAVIX AND FOLLOW UP TEE PERFORMED (B)(6) 2013 REPORTED A DECREASE IN THE TRANSAORTIC VALVE GRADIENTS (PEAK 41 MMHG, MEAN 22 MMHG). THIS WAS MAINTAINED AT AN ADDITIONAL FOLLOW-UP ECHO PERFORMED (B)(6) 2013. ADDITIONALLY IT WAS NOTED THAT THERE WAS MILD PVL, MINIMAL CENTRAL REGURGITATION, AND GRADIENTS WERE NORMAL IN THE PRESENCE OF A PROSTHETIC VALVE. THE DEVICE IS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTION FOR USE (IFU), VALVE STENOSIS IS A POTENTIAL RISK ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. VALVE STENOSIS MAY RESULT IN SYMPTOMS SUCH AS SOB AND DECREASED EXERCISE TOLERANCE, WHICH MAY BE ACCOMPANIED BY AN INCREASED GRADIENT ACROSS THE VALVE. THIS COULD BE DUE TO EARLY CALCIFICATION OF THE LEAFLETS, HOST TISSUE OVERGROWTH, THROMBOSIS, OR IN RARE CASES A NON-FUNCTIONING LEAFLET. IN THIS CASE THE CAUSE FOR THE VALVE STENOSIS IS UNKNOWN; HOWEVER THE STENOSIS AND NOTED GRADIENT INCREASE OCCURRED AFTER DISCONTINUING PLAVIX AND THEN REDUCED TO NORMAL VALUES AFTER RESTARTING PLAVIX. IT IS POSSIBLE THAT AFTER DISCONTINUING PLAVIX THERE WAS PLATELET AGGREGATION THAT RESULTED IN STENOSIS OF THE LEAFLETS. RE-INITIATION OF PLAVIX RESULTED IN NORMALIZING THE VALVE GRADIENT. 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT THE PATIENT WAS SEEN APPROXIMATELY TWO MONTHS POST TAVR FOR SHORTNESS OF BREATH AND LABORED BREATHING. TTE REVEALED NO CLOT, BUT THERE WAS A HIGH GRADIENT PEAK OF 77 IN THE PRESENCE OF THE SAPIEN VALVE. REPORTEDLY THE PATIENT WAS PUT BACK ON PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272773 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention