BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9491814 · Received December 18, 2019

    Report

    Report Number
    1645337-2019-25890
    Event Type
    Injury
    Date Received
    December 18, 2019
    Report Date
    November 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON (B)(6) 2020. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DEFLATION OF THE BREAST IMPLANT. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5842094, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. DURING VISUAL INSPECTION OF THE DEVICE A CREASE WAS OBSERVED ON THE POSTERIOR VIEW. LEAK TESTING REVEALED A TEAR WITHIN THE CREASE MEASURING LESS THAN 0.1 CM. ALSO, A VALVE LEAK WAS OBSERVED. NO OTHER ANOMALIES WERE OBSERVED. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR GAVE NO INDICATIONS OF INSTRUMENT DAMAGE. NO OTHER ANOMALIES OBSERVED. THE ANALYSIS WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THESE KIND OF FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH A TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE PROSTHESIS, CATALOG #3501650, LOT #5842094. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD A MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH SALINE PROSTHESES WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285007 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501650 5842094 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention