BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3943510 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01620
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE REGURGITATION INCLUDING MALPOSITION OF THE VALVE, IMPINGEMENT OF A LEAFLET DUE TO THE GUIDE WIRE, OVER INFLATION OF THE DEPLOYMENT BALLOON, POST DILATION OF THE IMPLANTED VALVE, AND SLOW RECOVERY OF ADEQUATE VENTRICULAR FLOW POST VALVE DEPLOYMENT AND RAPID PACING. ALL OF THESE FACTORS HAVE THE POTENTIAL TO CONTRIBUTE TO SUBOPTIMAL COAPTATION OF THE SAPIEN VALVE LEAFLETS AND CAUSE CENTRAL AORTIC INSUFFICIENCY. OCCASIONALLY THERE ARE CASES WHERE THE ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER NATIVE VALVE LEAFLET ASSESSMENT, TAKING INTO CONSIDERATION THE LENGTH, BULKINESS AND DISTRIBUTION OF CALCIUM ON THE NATIVE LEAFLETS TO DETERMINE WHETHER VALVE PERFORMANCE WILL BE IMPAIRED. DURING THE MANUFACTURING PROCESS, ALL SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR COAPTATION PRIOR TO RELEASE FOR DISTRIBUTION. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION WOULD CONTRIBUTE TO THE EVENT. IN THIS CASE THE EXACT CAUSE OF THE VALVE REGURGITATION COULD NOT BE DETERMINED; HOWEVER, AS REPORT IT WAS THOUGHT THE VALVE WAS IN A TOO AORTIC POSITION, WHICH CAUSED THE VALVE REGURGITATION. 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

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS FOLLOWING A VALVE IN VALVE PROCEDURE, (REFERENCE MANUFACTURER REPORT NUMBER 2015691-2014-01169) MODERATE TO SEVERE CENTRAL REGURGITATION WAS NOTED, IT WAS THOUGHT THE VALVE WAS DEPLOYED TOO AORTIC WITHIN THE PRIOR VALVE. IT WAS DECIDED TO PLACE A THIRD SAPIEN VALVE WITHIN THE OTHER TWO. THE PATIENT WAS BROUGHT BACK IN FOR A TRANSFEMORAL TAVR PROCEDURE. THE SAPIEN VALVE WAS SUCCESSFULLY DEPLOYED WITHIN THE TWO VALVES. FINAL TEE SHOWED ZERO CENTRAL REGURGITATION AND MILD PARAVALVULAR LEAK, WHICH WAS PRESENT FROM THE PREVIOUS IMPLANT. UPON REMOVAL OF THE RETROFLEX 3 INTRODUCER SHEATH A SMALL DISSECTION FLAP WAS SEEN IN THE LEFT EXTERNAL ILIAC ARTERY. A STENT GRAFT WAS PLACED TO CORRECT THE DISSECTION AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422275 SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention