BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7664252 · Received July 5, 2018

    Report

    Report Number
    1645337-2018-04080
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/6/2018, MENTOR RECEIVED INFORMATION THAT IDENTIFIED THE INITIALLY REPORTED UNKNOWN DEVICE: BRAND NAME: MENTOR SMOOTH ROUND MODERATE PROFILE, PROCODE: FWM, COMMON DEVICE NAME: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE, CATALOG: 3501660, LOT: 269754, UNIQUE IDENTIFIER (UDI): (B)(4), PMA/ 510(K): P990075. ALSO ON 7/31/2018, MENTOR RECEIVED ADDITIONAL INFORMATION: DATE OF EVENT: (B)(6) 2018. PATIENT AGE AT THE TIME OF EVENT: (B)(6) (B)(4). PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS. BAKER GRADE IV CAPSULAR CONTRACTURE WAS ALSO REPORTED ON THE RIGHT BREAST PROSTHESIS. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH NATRELLE INSPIRA SOFTTOUCH BREAST IMPLANTS 415CC GEL PROSTHESES ON (B)(6) 2018; CATALOG # SSF-415, S/NS (B)(4). THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 7/31/2018. DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AT MENTOR WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, THE PRODUCT EVALUATION TEAM OBSERVED A CREASE ON THE POSTERIOR VIEW EXTENDING TO THE ANTERIOR. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND REVEALED ONE LEAK CAUSED BY A RENT MEASURING APPROXIMATELY 0.1 CM, DISCOVERED WITHIN THE CREASE ON THE POSTERIOR VIEW. NO OTHER ANOMALIES WERE FOUND. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE; THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 269754 WAS REVIEWED ON 8/7/2018, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THESE 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 AS CAPSULAR CONTRACTURE OR 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. WITH THE INFORMATION PROVIDED, THE PRODUCT EVALUATION TEAM CONCLUDED THE CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(4) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN UNKNOWN MENTOR SALINE PROSTHESIS. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT WITH UNSPECIFIED NON-MENTOR IMPLANTS ON (B)(4) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506217 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 269754

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention