BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3032971 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19719
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT REVEAL ANY ISSUES REGARDING THE AFFECTED WORK ORDERS FOR FINAL/PACKAGING AND SUB ASSEMBLY LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO SIMILAR COMPLAINTS OF WHITE PARTICULATE FROM THIS WORK ORDER. ALTHOUGH A REVIEW OF THE COMPLAINT HISTORY CONFIRMED COMPLAINTS OF THE WHITE CONTAMINANTS ATTRIBUTED TO MANUFACTURING NON-CONFORMANCE, THE TYPE AND SOURCE OF THE CONTAMINANT FOR THIS COMPLAINT COULD NOT BE DETERMINED WITHOUT A RETURNED PRODUCT EVALUATION. DURING MANUFACTURING, THE SAPIEN VALVES ARE 100% VISUALLY INSPECTED FOR PROPER LEAFLET ASSEMBLY, SKIRT ATTACHMENT, AND FRAME-VALVE ASSEMBLY UNDER 8X MAGNIFICATION PER PROCEDURES. ALL SUTURES ARE INSPECTED FOR CORRECT PLACEMENT AND NUMBER OF STITCHES. ANY FRAYS AND LOOSE/SLACK SUTURES ARE NOT ACCEPTABLE. PRIOR TO FINAL PACKAGING, A 100% VISUAL INSPECTION IS PERFORMED PER PROCEDURES TO LOOK FOR FOREIGN MATERIALS ON THE VALVES AS WELL AS INSIDE THE JARS. THESE INSPECTIONS MAKE IT UNLIKELY THAT THE CONTAMINANT WAS INTRODUCED DURING MANUFACTURING OR ORIGINATE FROM THE SUTURES OF THE VALVE. THE COMPLAINT COULD NOT BE CONFIRMED, AND NO LABELING INADEQUACIES WERE IDENTIFIED. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDS CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, AFTER OPENING THE JAR OF THE VALVE, AN EXTRA FIBER HANGING ACROSS THE VALVE AREA WAS NOT NOTICED. THE VALVE WAS REMOVED FROM THE JAR TO CONTINUE INSPECTION, HOWEVER, THE FIBER REMAINED. THE VALVE WAS PLACED BACK IN THE VALVE JAR TO BE RETURNED. FURTHER INVESTIGATION REVEALED THAT THE EXTRA FIBER HANGING APPEARED TO BE INHERENT AND MAY HAVE BEEN FROM THE STITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135820 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1