BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAL SILTEX RND MLV 250CC

    MDR report key: 7838334 · Received August 31, 2018

    Report

    Report Number
    1645337-2018-05318
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    July 8, 2018
    Report Date
    August 7, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A 54 YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE SAL SILTEX RND MLV 250CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, PATIENT UNDERWENT REMOVAL OF THE IMPLANT ON (B)(6) 2018. THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. THE DEVICE WAS RETURNED TO MENTOR WITH FLUID THAT APPEARED CLEAR INSIDE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. YELLOW MATERIAL WAS OBSERVED ON THE SHELL SURFACE. VISUAL EVALUATION OF THE DEVICE REVEALED PARALLEL LINES OF SILTEX CRACKING ON THE POSTERIOR VIEW. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES, AND ONE LEAK WAS FOUND WITHIN THE SILTEX CRACKING. THE LEAK WAS CAUSED BY A RENT MEASURING LESS THAN 0.1 CM IN LENGTH. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND SILTEX CRACKING OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX SALINE-FILLED DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF STRESSES CAUSED BY FOLDING OF THE SHELL IN-VIVO. 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. 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 · 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. 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 PRODUCTS: SAL SILTEX RND MLV 250CC 250CC SALINE BREAST IMPLANT, CATALOG # 3542835M, LOT # 74203. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE SAL SILTEX RND MLV 250CC 250CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, PATIENT UNDERWENT REMOVAL OF THE IMPLANT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680586 SAL SILTEX RND MLV 250CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 73817

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention