BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2843853 · Received November 23, 2012

    Report

    Report Number
    2015691-2012-18703
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE MEDICAL RECORDS WERE RETURNED FOR REVIEW. PER THE OPERATION REPORT, ANGIOGRAPHY OF THE MAIN PULMONARY ARTERY DEMONSTRATED MODERATE PULMONIC INSUFFICIENCY, NARROWING OF THE VALVE AND MILD DILATION OF THE PROXIMAL LEFT PULMONARY ARTERY. FOLLOWING BALLOON INFLATIONS WITH A 22MM ATLAS BALLOON, A REPEAT ANGIOGRAPHY DEMONSTRATED IMPROVED NARROWING AND SEVERE PULMONIC INSUFFICIENCY. ANGIOGRAPHY FOLLOWING DEPLOYMENT OF A 26MM EDWARDS SAPIEN VALVE DEMONSTRATED NO PULMONIC INSUFFICIENCY WITH GOOD APPOSITION OF THE NEW STENT WITHIN THE PREVIOUSLY PLACED STENT. FURTHERMORE, THERE WAS NO EVIDENCE OF DISSECTION OR EXTRAVASATION. AORTIC ROOT ANGIOGRAPHY DEMONSTRATED NORMAL SIZED AORTIC ROOT, NORMAL FLOW OF DYE INTO THE LEFT MAIN PULMONARY ARTERY, AND THE SAPIEN VALVE DID NOT APPEAR TO IMPINGE ON THE CORONARY ARTERIES. 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 ROOT CAUSE OF THE REPORTED EVENT CANNOT NOT BE CONFIRMED. 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.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE COMPASSION CLINICAL TRIAL THAT APPROXIMATELY 4.5 YEARS POST IMPLANTATION OF A 23MM EDWARDS SAPIEN TRANSCATHETER HEART VALVE IN THE PULMONIC POSITION THE PATIENT HAD SEVERE RE-NARROWING OF THE VALVE. THE DECISION WAS MADE TO DILATE THE PREVIOUSLY PLACED 23MM EDWARDS SAPIEN VALVE AND PERFORM A VALVE IN VALVE PROCEDURE WITH A 26MM EDWARDS SAPIEN VALVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention