BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTOURA BREAST TISSUE EXPANDER

    MDR report key: 17585124 · Received August 21, 2023

    Report

    Report Number
    1645337-2023-09745
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    August 2, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317009498
    PMA / PMN Number
    K150777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON AUGUST 22, 2023, MENTOR BECAME AWARE OF THE FOLLOWING AND CORRESPONDING FIELDS HAVE BEEN UPDATED ON THIS FORM: FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "ARTOURA BREAST TISSUE EXPANDER". FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "TEXP140RH". FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "9820035". FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO "(B)(4)." FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "K150777". A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 4, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS PER PAPERWORK RECEIVED WITH THE DEVICE, FOLLOWING INFORMATION HAS BEEN UPDATED ON THIS FORM: PATIENT'S AGE UNDER FIELD A2 HAS BEEN UPDATED TO "36", PATIENT'S ETHNICITY HAS BEEN UPDATED TO "HISPANIC/LATINO", DATE OF ADVERSE EVENT UNDER B3 HAS BEEN UPDATED TO AUGUST 2, 2023 REPLACEMENT EXPANDER CATALOG NUMBER USED ON AUGUST 2, 2023 WAS "TEXP1040RH". MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON OCTOBER 10, 2023, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT A TEAR WAS NOTED BETWEEN THE BLADDER AND SHELL ON THE ARTOURA HP BREAST TE 600CC TISSUE EXPANDER. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. BASED ON THE CURRENT INFORMATION, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH MENTOR¿S QUALITY SYSTEM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE ISSUE REPORTED WERE IDENTIFIED. ADDITIONALLY, PROCESSES, EQUIPMENT, OR TOOLS THAT COULD CAUSE A TEAR IN THE SHELL WERE EVALUATED AND WERE IDENTIFIED AS A NON-CONTRIBUTING FACTOR FOR THE TEAR FOUND. THE PROCESS CONTROLS AND DATA RECORDS COLLECTED FOR THE DEFLATED TISSUE EXPANDER ARE WITHIN SPECIFICATION. THE TEAR REPORTED ON THE PRODUCT COMPLAINT IS NOT ABLE TO BE CONFIRMED AS A MANUFACTURING DEFECT. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH UNKNOWN SIZE UNKNOWN TISSUE EXPANDERS AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT DEFLATION. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528265 ARTOURA BREAST TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9820035 00081317009498

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention