BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3011329 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19582
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. A VISUAL ANALYSIS WAS CONDUCTED ON THE RETURNED DEVICE. UPON VISUAL INSPECTION, A BLACK FIBER WAS FOUND ON ONE OF THE LEAFLETS ON THE INFLOW (ROUGH) SIDE OF THE VALVE AND WAS ISOLATED FOR CHEMISTRY ANALYSIS. UPON OBSERVATION ALL SUTURES WERE INTACT WITHOUT ANY FRAYS OR TEARS AND DID NOT SHOW ANY DAMAGE TO THE FRAME, SKIRT, LEAFLET AND THE VALVE. FURTHERMORE, THE CHEMISTRY ANALYSIS OF THIS FIBER REVEALED THAT THE PARTICULATE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO CELLOPHANE-LIKE MATERIAL. THE BILL OF MATERIALS (BOM) FOR THE VALVE INCLUDING PACKAGING MATERIAL WAS REVIEWED AND DID NOT FIND ANY BLACK CELLOPHANE-BASED MATERIALS. A DEVICE HISTORY RECORD (DHR) REVIEW REVEALED THE AFFECTED WORK ORDER SPECIFICALLY THE FINAL/PACKAGING LOT DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE SOURCE OF THE PARTICULATE COULD NOT BE DETERMINED, HOWEVER, IT IS POSSIBLE THAT LINEN FIBER FROM A MANUFACTURING TECHNICIAN'S CLOTHING MIGHT HAVE BEEN INADVERTENTLY INTRODUCED ONTO THE VALVE DURING MANUFACTURING. EDWARDS ENFORCES STRICT GOWNING PROCEDURES IN EACH PRODUCTION CLEANROOM. THE SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR LEAFLET TISSUE LEAFLET ATTACHMENT, AND VALVE GENERAL APPEARANCE UNDER 8X MAGNIFICATION. THIS INSPECTION IS ALSO PERFORMED AGAIN BEFORE HOLDER ATTACHMENT. AFTER THE HOLDER ATTACHMENT, THE VALVES ARE 100% VISUALLY INSPECTED FOR SUTURE FRAYS AND CONTAMINATION OF THE HOLDER. PRIOR TO FINAL PACKAGING, A 100% VISUAL INSPECTION IS PERFORMED TO LOOK FOR FOREIGN MATERIALS ON THE VALVES AS WELL AS INSIDE THE JARS. A MANUFACTURING DEFECT WAS CONFIRMED ON THE RETURNED SAMPLE. TO MITIGATE THIS PARTICULATE CONTAMINATION ISSUE, A CORRECTIVE ACTION WAS IMPLEMENTED TO ADD CLARIFICATION TO PROCEDURES ON HOW AND WHERE TO DISCARD TEMPORARY SUTURES AS WELL AS OTHER PARTICULATES. THIS VALVE WAS MANUFACTURED BEFORE THE CORRECTIVE ACTION WAS IMPLEMENTED. ADDITIONALLY, THE IFU AND DEVICE PREP 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. 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 · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, PRIOR TO PLACING THE VALVE INTO THE RINSE SOLUTION, A SMALL PIECE OF DEBRIS WAS NOTICED ON THE LEAFLET. THE DEBRIS LOOKED LIKE A SMALL BLACK FIBER. THE MEDICAL TEAM WAS UNABLE TO REMOVE THE DEBRIS AND A DECISION WAS MADE TO OPEN A NEW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114603 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1