BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 SAPIEN DELIVERY SYSTEM

    MDR report key: 3083409 · Received April 29, 2013

    Report

    Report Number
    2015691-2013-19938
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. 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

    THE RETROFLEX3 DELIVERY SYSTEM WAS RETURNED TO EDWARDS IN A USED CONDITION. THE BALLOON ON THE RETROFLEX3 DELIVERY SYSTEM WAS VISUALLY INSPECTED FOR ANY DEFECTS. A LONGITUDINAL TEAR WAS OBSERVED ALONG THE LENGTH OF THE BALLOON. THE VISUAL INSPECTION OF THE LONGITUDINAL TEAR LINE REVEALED NO SURFACE DEFECTS SUCH AS SCRATCHES, FISH EYES, AND GEL SPOTS AT THE TEAR LOCATION. DIMENSIONAL ANALYSIS WAS TAKEN FOR THE SINGLE WALL THICKNESS AT THE DISTAL, MIDDLE, AND PROXIMAL SECTIONS. THE DISTAL, MIDDLE, AND PROXIMAL CALCULATED DOUBLE WALL THICKNESS MEET THE RETROFLEX 3 DOUBLE WALL SPECIFICATION. THE COMPLAINT WAS CONFIRMED FOR A BALLOON BURST, BUT NO MANUFACTURING NON-CONFORMANCE COULD BE IDENTIFIED DURING EVALUATION. NO OTHER VISUAL ABNORMALITIES WERE OBSERVED ON THE COMPLAINT BALLOON. DUE TO THE UNAVAILABILITY OF THE CRIMPER, IT CANNOT BE DETERMINED IF AN ISSUE WITH THE BALLOON GAGE (SUCH AS FLASH, BURRS) COULD HAVE CONTRIBUTED TO THE BURST. SIMILAR COMPLAINTS POINTED TO OVER-PRESSURIZATION OF THE BALLOON AS THE CAUSE OF THE REPORTED BURST WHICH MAY HAVE OCCURRED IN THIS CASE. DURING MANUFACTURING, THE BALLOON COMPONENT IS 100% VISUALLY INSPECTED FOR DEFECTS, BURST PRESSURE TESTED ON A SAMPLING PLAN, AND 100% DIMENSIONALLY INSPECTED. THE BALLOON IS ALSO INFLATED TO ENSURE PROPER SIZE AND INSPECTED FOR MECHANICAL DAMAGE. THE DELIVERY SYSTEM IS LEAK TESTED AFTER THE BALLOON IS PLEATED AND FOLDED. THIS MAKES IT UNLIKELY THAT A PRE-EXISTING PIN HOLE OR DEFECT ON THE BALLOON COULD HAVE CAUSED THE RUPTURE. THE BALLOON GAGE HAS A 100% MANUFACTURING INSPECTION AND QUALITY INSPECTION TO ENSURE THAT THE ID OF THE GAGE IS SMOOTH WITHOUT ANY BURRS, PROTRUSIONS, OR OTHER DAMAGES. THIS MAKES IT UNLIKELY THAT A DEFECT WITH THE GAGE CONTRIBUTED TO THE RUPTURE. NO LABELING OF IFU INADEQUACIES HAVE BEEN IDENTIFIED AND REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDS THE CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO FURTHER CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT WHILE THE NURSE WAS SIZING THE BALLOON OF THE RETROFLEX 3 DELIVERY SYSTEM IN THE BALLOON GAUGE PRIOR TO USE, THE BALLOON POPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183585 RETROFLEX 3 SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59334673

    Patients

    Seq Age Sex Outcome Treatment
    1