BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8107666 · Received November 27, 2018

    Report

    Report Number
    1645337-2018-07058
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 6, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, ADDITIONAL INFORMATION WAS RECEIVED AND THE PRODUCT INVESTIGATION WAS UPDATED. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. WHITE AND YELLOW MATERIAL WERE OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, MENTOR PRODUCT ANALYSIS LAB OBSERVED A RENT MEASURING APPROXIMATELY < 0.1 CM ON THE ANTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT REVEALED PARALLEL STRIATIONS. A LINE OF SHELL ABRASION WAS OBSERVED IN THE CREASE, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND IN THE DEVICE. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS. THIS TYPE OF STRIATIONS IS MORE CONCLUSIVE TO SHARP INSTRUMENT DAMAGE RATHER THAN SHELL FAILURE DUE TO WEAR. AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE AND YELLOW MATERIAL OBSERVED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5903456 WAS REVIEWED 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. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT REVEALED PARALLEL STRIATIONS WHICH ARE SIMILAR TO MARKINGS MADE BY AN INSTRUMENT PERFORATING SILICONE MATERIAL. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. WHITE AND YELLOW MATERIAL WERE OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, MENTOR PRODUCT ANALYSIS LAB OBSERVED A CREASE ON THE POSTERIOR VIEW. A LINE OF SHELL ABRASION WAS OBSERVED IN THE CREASE, SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE FOUND. THE COMPLAINT OF DEFLATION WAS NOT CONFIRMED SINCE NO RENTS WERE FOUND ON THE REPORTED DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE CREASE AND SHELL ABRASION OR THE ORIGIN OF THE WHITE AND YELLOW MATERIAL OBSERVED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE CREASE AND SHELL ABRASION OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5903456 WAS REVIEWED 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: UNDER-INFLATION OR OVER-INFLATION 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. (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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, 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. CONCOMITANT MEDICAL PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE CATALOG: 3501660 LOT: 5903456 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 375CC SALINE BREAST PROSTHESES. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS VISIBLY OBSERVED BY THE PATIENT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH (LEFT) MENTOR MEMORYGEL BREAST IMPLANT 500CC GEL AND (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT 550CC GEL BREAST PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946064 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5903456 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SEE H10