BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 2973178 · Received February 21, 2013

    Report

    Report Number
    2015691-2013-19351
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION : METHOD: DIMENSIONAL TESTING. RESULTS: THE RF3 DELIVERY DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. PRELIMINARY INVESTIGATION REVEALED A SMALL TEAR ON THE BALLOON. IN ADDITION, THE ENGINEER NOTED THE BALLOON THICKNESS WAS MEASURED AND FOUND TO MEET SPECIFICATIONS. FOLLOW UP EXAMINATION PENDING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE CLINICAL SPECIALIST, INDICATED THAT THE LEAK WAS SPECIFICALLY NOTED DURING THE INITIAL PREP/DE-AIRING OF THE BALLOON. THE RETROFLEX 3 DELIVERY SYSTEM WAS RETURNED TO EDWARDS FOR EVALUATION. VISUAL AND DIMENSIONAL INSPECTIONS WERE PERFORMED. VISUAL INSPECTION REVEALED A SMALL TEAR ON THE BALLOON WALL LOCATED JUST PROXIMAL OF THE DISTAL NOSE CONE WHICH APPEARED TO BE DUE TO MECHANICAL DAMAGE. VISUAL INSPECTION ALONG THE BALLOON DID NOT REVEAL ANY SURFACE DEFECTS. DOUBLE WALL THICKNESS MEASUREMENTS OF THE WORKING LENGTH OF THE BALLOON WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE RF3 DELIVERY DEVICE WAS PERFORMED. THE AFFECTED DEVICE WORK ORDERS AND PV TESTING WERE EVALUATED AND DID NOT REVEAL ANY ISSUES DURING MANUFACTURING THAT COULD BE RELATED TO THE EVENT. REVIEW OF COMPLAINT HISTORY REVEALED FOUR SIMILAR COMPLAINTS OF BALLOON LEAKAGE DURING PREP. ENGINEERING EVALUATION FOR THE DEVICE THAT WAS RETURNED REVEALED NO MANUFACTURING NON-CONFORMITIES, AND POINTED TO MECHANICAL DAMAGE THAT OCCURRED AFTER THE DEVICE LEFT THE EDWARDS FACILITY AS THE ROOT CAUSE OF THE COMPLAINT. THE COMPLAINT OF A LEAK WAS CONFIRMED. THE BALLOON COMPONENT IS 100% VISUALLY INSPECTED FOR DEFECTS, AND 100% DIMENSIONALLY INSPECTED DURING THE MANUFACTURING PROCESS. EVERY BALLOON IS ALSO 100% INSPECTED FOR SEPARATION AT BOND SITES, DETERIORATION, AND CONTAMINATION AS WELL AS INFLATED TO INSPECT SIZE. AFTERWARDS, A BALLOON COVER IS PLACED OVER THE BALLOON TO PROTECT IT AFTER THE PLEAT AND FOLD PROCESS AND THE FINAL FINISHED DEVICE IS LEAK TESTED PER INTERNAL PROCEDURES. THE OPERATOR REMOVES THE BALLOON OVER PRIOR TO FINAL INSPECTION AND PACKAGING. THIS MAKES IT HIGHLY UNLIKELY THAT A MANUFACTURING NON CONFORMANCE COULD HAVE CAUSED A RUPTURE. MOREOVER, PER THE FMEA, THE DAMAGE ON THE DELIVERY SYSTEM DETECTED BEFORE USE HAS A SEVERITY RANKING OF 1. THE TYPE OF MECHANICAL DAMAGE SEEN IN THE RETURNED DEVICE HAS RENDERED THE DEVICE INCAPABLE OF BEING PREPPED PER IFU OR DEPLOYING A VALVE; THEREFORE, FAILURE MODES RELATING TO ISSUES DEPLOYING A VALVE DO NOT APPLY IN THIS CASE. THE COMPLAINT WAS CONFIRMED, BUT NO MANUFACTURING NON-CONFORMANCES WERE FOUND IN THE RETURNED SAMPLE. NO LABELING OR IFU INADEQUACIES HAVE BEEN IDENTIFIED AND REVIEW OF THE COMPLAINT HISTORY DID NOT REVEAL THAT THE OCCURRENCE RATE EXCEEDS THE JANUARY 2013 CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST (CS), DURING DEVICE PREPARATION FOR THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A SMALL PINHOLE LEAK WAS NOTED ON THE RF3 DELIVERY SYSTEM BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75611 RETROFLEX 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26US 59135239

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR