BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE

    MDR report key: 19110227 · Received April 15, 2024

    Report

    Report Number
    1645337-2024-04487
    Event Type
    Injury
    Date Received
    April 15, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    10081317028243
    PMA / PMN Number
    K161176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 08, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION. THE DEVICE IDENTITY WAS UPDATED WITH THE FOLLOWING INFORMATION: BRAND NAME: MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SIZE: 475CC LOT: 9760314 CATALOG: SDC130H 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. PATIENT IDENTIFIER WAS ADDED. ON MAY 21, 2024, MENTOR RECEIVED THE DEVICE FOR EVALUATION. ON MAY 22, 2024, MENTOR COMPLETED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE WAS FOUND TO HAVE A TEAR ON THE ANTERIOR VIEW AT THE UNION OF THE SHELL AND BLADER. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: THE PATIENT SHOULD BE ADVISED THAT VIGOROUS BODY MOVEMENT (E.G., PHYSICAL EXERCISE) OR EXCESSIVE MANIPULATION OR TRAUMA IN THE REGION OF THE EXPANDER MAY CAUSE STRESS TO THE DEVICE AND RESULT IN SUBSEQUENT DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR SALINE BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339855 MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9760314 10081317028243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention