BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTOURA BREAST TISSUE EXPANDER

    MDR report key: 8363100 · Received February 22, 2019

    Report

    Report Number
    1645337-2019-08791
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    October 22, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317009498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/25/19, IT WAS REPORTED TO MENTOR THAT A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 6992234 NUMBER, AND NON-CONFORMANCES WERE IDENTIFIED. AN INTERNAL NONCONFORMING REPORT HAS BEEN INITIATED TO ADDRESS THE ISSUE. ON 12/10/2015, THE MANUFACTURING SUPERVISOR IDENTIFIED A DISCREPANCY WHERE THE SHEETING LOT 7007725 PART NUMBER 400574-003) WAS FOUND WITH AN EXPIRATION DATE OF 01/07/2016. HOWEVER, PER THE SPECIFICATION (DRWG400574) THE SHELF LIFE SHOULD BE 4 WEEKS FROM THE CALENDAR DATE WHICH IS 12/30/2015. A SECOND INTERNAL CORRECTIVE ACTION IS BEING OPENED FOR THE ISSUE. LOTS WERE ERRONEOUSLY ADDED TO A PD PLAN THAT WAS TO BE DISPOSITIONED AS USE AS IS. THE LOTS ARE REMOVED FROM THE PD PLAN IN THE INTERNAL CORRECTIVE ACTION AND SYSTEM LIMITATIONS WILL NOT ALLOW THE LOTS TO BE ADDED TO THE SAME CORRECTIVE ACTION TWICE SO A SECOND CORRECTIVE ACTION IS OPENED TO DISPOSITION THE PRODUCT UNDER A NEW PD PLAN. PER MENTOR IFU, TISSUE EXPANDERS ARE NOT INTENDED FOR IMPLANTATION BEYOND 6 MONTHS. THEREFORE, THIS DEVICE WAS USED IN AN OFF LABEL MANNER. SINCE THE PRODUCT HAS NOT BEEN RETURNED, IT HAS BEEN CONCLUDED THAT DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AS STATED IN THE IFU. THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 6992234 NUMBER, AND NON-CONFORMANCES WERE IDENTIFIED. DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, MANUAL MASSAGE, AND INTIMATE PHYSICAL CONTACT; STRESS OR TRAUMA TO THE BREAST, MECHANICAL DAMAGE PRIOR TO OR DURING SURGERY, VALVE MALFUNCTIONS OR TISSUE INGROWTH INTO THE VALVE, LEAKAGE FROM THE FILL TUBE, VALVE OR INJECTION DOME (SPECTRUM DEVICES), UNDERFILLING OR OVERFILLING THE IMPLANT (SEE PRODUCT LABEL), DAMAGE FROM SURGICAL INSTRUMENTS, DAMAGE DURING FILL TUBE REMOVAL, DAMAGE DURING THE FILLING STAGE, CLOSED CAPSULOTOMY, SHELL ABRASION, CAPSULAR CONTRACTURE, AND ORIGINS WHICH ARE SIMPLY UNKNOWN. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. THE MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 600CC ON (B)(6) 2017 EXPERIENCED RIGHT SIDE EXPANDER DEFLATION THAT WAS OBSERVED ON (B)(6) 2018. THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2018. PER MENTOR IFU, TISSUE EXPANDERS ARE NOT INTENDED FOR IMPLANTATION BEYOND 6 MONTHS. THEREFORE, THIS DEVICE WAS USED IN AN OFF LABEL MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156581 ARTOURA BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 6992234 00081317009498

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention