BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 3013385 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19599
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSES WERE CONDUCTED ON THE RETURNED DEVICE. UPON VISUAL INSPECTION, A LONGITUDINAL TEAR WITH SCRATCHES ALONG BOTH SIDES OF THE TEAR, AND SCRATCHES ON THE REMAINDER OF THE BALLOON, WERE OBSERVED. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE SINGLE WALL THICKNESS OF THE BALLOON. THE CALCULATED DOUBLE WALL THICKNESS MEASUREMENTS OF THE DISTAL AND PROXIMAL REGION MET SPECIFICATIONS. THE MIDDLE DOUBLE WALL THICKNESS WAS SLIGHTLY OVER SPECIFICATION WHICH IS MOST LIKELY DUE TO THE CREASES/WRINKLES ON THE WALL OF THE BALLOON CREATING AN EXTRA THICKNESS ON THE BALLOON SURFACE. THE CONDITION OF THE RETURNED SAMPLE MAY HAVE CAUSED THE MEASUREMENT TO BE BIASED HIGH. IT IS UNLIKELY THAT THESE MEASUREMENT RESULTS INDICATING THICKER MATERIAL WOULD CORRELATE WITH IMPAIRED BALLOON RESISTANCE TO BURST. AS LONGITUDINAL SCRATCHES WERE OBSERVED ALONG THE BALLOON, IT WAS SUSPECTED THAT THE BALLOON GAGE ITSELF WAS SCRATCHING THE BALLOON. AS LONGITUDINAL SCRATCHES WERE OBSERVED ALONG THE BALLOON, IT WAS SUSPECTED THAT THE BALLOON GAGE ITSELF WAS SCRATCHING THE BALLOON. A FEASIBILITY STUDY WAS PERFORMED WHERE SAMPLE DELIVERY SYSTEMS WERE SIZED WITH A BALLOON GAGE. THE STUDY REVEALED THAT A GOOD BALLOON GAGE (NO VISUAL INDICATION OF FLASH, BURRS, OR SURFACE DEFECTS) CAN INDUCE LONGITUDINAL SCRATCHES ON THE BALLOON (SIMILAR TO THE RETURNED COMPLAINT UNIT). THE SCRATCHES WERE APPARENT WHEN THE BALLOON MET MINIMAL RESISTANCE IN THE GAGE. IT SHOULD ALSO BE NOTED THAT EVEN WITH THE PRESENCE OF THE SCRATCHES, THE SAMPLE BALLOONS DID NOT BURST UNDER 7 ATM'S OF PRESSURE AND COULD STILL BE MANIPULATED THROUGH THE RING WITH NO BURST. A DEVICE HISTORY RECORD (DHR) REVIEW REVEALED THE AFFECTED WORK ORDERS, SPECIFICALLY RF3 PACKAGING, RF3 ASSEMBLY, BALLOON, CRIMPER ASSEMBLY AND BALLOON GAGE LOTS DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE COMPLAINT WAS CONFIRMED, HOWEVER DUE TO THE UNAVAILABILITY OF THE CRIMPER, IT CANNOT BE DETERMINED IF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING OR IFU INADEQUACIES HAVE BEEN IDENTIFIED AND REVIEW OF THE COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDS CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION IS POSSIBLE/REQUIRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. UPON INITIAL EVALUATION A LONGITUDINAL BURST WAS CONFIRMED IN ADDITION TO LONGITUDINAL SCRATCHES OBSERVED NEAR THE TEAR LINE ON BOTH SIDES OF THE TEAR. THE ENGINEERING EVALUATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE ENGINEERING EVALUATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING DEVICE PREPARATION THE DELIVERY SYSTEM BALLOON RUPTURED DURING MANIPULATION THROUGH THE SIZING RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116740 EDWARDS RETROFLEX 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59348384

    Patients

    Seq Age Sex Outcome Treatment
    1