BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 SAPIEN DELIVERY SYSTEM

    MDR report key: 3172701 · Received June 17, 2013

    Report

    Report Number
    2015691-2013-20363
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DUE TO NO DEVICE (OR PHOTO) BEING RETURNED FOR EVALUATION THE COMPLAINT OF CONTAMINATION COULD NOT BE CONFIRMED. AS THE AFFECTED DEVICE WAS NOT RETURNED, THE INVESTIGATION WAS LIMITED TO REVIEW OF THE DHR, PHYSICIAN TRAINING, IFU, AND THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS. A DHR REVIEW DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONALLY A COMPLAINT HISTORY REVIEW DID NOT REVEAL ANY EVENTS CONSIDERED TO BE RELATED AND THE OCCURRENCE RATE DID NOT EXCEED THE MAY 2013 CONTROL LIMITS FOR THIS FAILURE MODE. DURING MANUFACTURING, CRIMPERS ASSEMBLIES ARE 100% INSPECTED, WHICH INCLUDES THE FOLLOWING INSPECTIONS: ENSURE THAT THERE ARE NO MISSING PARTS. CRIMPER MUST BE FREE OF SURFACE CONTAMINATION, PHYSICAL DAMAGE, AND COSMETIC DEFECTS. THE SURFACE AND EDGES OF THE JAW INSIDE DIAMETER MUST BE SMOOTH WITHOUT ANY BURRS, PROTRUSIONS, OR OTHER DAMAGES. THESE INSPECTIONS MAKE IT UNLIKELY THAT CONTAMINATION WAS PRESENT AT THE TIME OF MANUFACTURING. IT SHOULD BE NOTED THAT THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFUL. 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. 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 A SMALL WHITE OBJECT WAS DISCOVERED ON THE RETROFLEX 3 DELIVERY SYSTEM BALLOON AFTER CRIMPING THE VALVE. REPORTEDLY THE OBJECT WAS LESS THAN 1MM LONG AND APPROX THE DIAMETER OF 2 HAIRS. THE OBJECT WAS REMOVED WITHOUT INCIDENT AND THE CRIMPED VALVE AND DELIVERY SYSTEM WERE EXAMINED FOR ANY OTHER ISSUES. NO OTHER PROBLEMS WERE FOUND AND THE VALVE WAS IMPLANTED WITHOUT INCIDENT. THE OBJECT WAS BELIEVED TO HAVE ORIGINATED FROM THE CRIMPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273492 RETROFLEX 3 SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26

    Patients

    Seq Age Sex Outcome Treatment
    1