BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7691044 · Received July 16, 2018

    Report

    Report Number
    1645337-2018-04286
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 26, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/18/2018, THE MENTOR FAILURE ANALYSIS LAB 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. ON 07/24/2018, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 09/24/2018, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. THE DEVICE CONTAINED NO FLUID UPON RECEIPT BY MENTOR. TWO DEVICES WERE RECEIVED BY MENTOR. THE DEVICE (A) CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. THE PRODUCT EVALUATION (PE) TEAM¿S VISUAL EXAMINATION OF THE DEVICE REVEALED A RENT ON THE ANTERIOR VIEW MEASURING APPROXIMATELY 0.3 CM. MICROSCOPIC EXAMINATION OF THE RENT EDGES GAVE NO INDICATION AS TO ITS CAUSE. NO OTHER ANOMALIES WERE FOUND. THE DEVICE (B) CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING VISUAL EXAMINATION, PE OBSERVED THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND A LEAKAGE WAS DETECTED AT VALVE. 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. PE CONCLUDED THAT THE RENT AND VALVE LEAK OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. LEAK TESTING REVEALED A THIRD LEAKAGE SITE DISCOVERED AT VALVE REVIEW OF THIS EVENT AS WELL AS SIMILAR EVENTS HAVE IDENTIFIED THE FOLLOWING POSSIBLE SOURCES OF LEAKAGE FROM THE VALVE OF THE DEVICE: TISSUE INGROWTH INTO THE VALVE IS A KNOWN POTENTIAL REACTION FOR THIS DEVICE AND HAS BEEN IDENTIFIED AS A POSSIBLE CAUSE FOR DEFLATION. DISLODGED VALVE MATERIAL FROM A VALVE PUNCTURE OR TEAR. WATER SOLUBLE CRYSTAL-LIKE MATERIAL (RESIDUAL NACL FROM THE FILL SOLUTION); EXTERNAL CONTAMINANT SUCH AS LINT, DUST, TALC, SURGICAL GLOVE POWDER, DRAPE AND SPONGE LINT, SKIN OILS AND OTHER SURFACE CONTAMINANTS DEPOSITED ON AN IMPLANT DURING HANDLING PRIOR TO SURGERY OR DURING PREPARATION OF THE DEVICE FOR SHIPMENT TO MENTOR FOR EVALUATION. SEPARATED VALVE MATERIAL LODGED BETWEEN THE VALVE BODY AND THE VALVE SEAT MOST LIKELY THE RESULT OF DAMAGE ASSOCIATED WITH THE DIAPHRAGM VALVE. EXCESS SILICONE-LIKE MATERIAL MOST LIKELY THE RESULT OF FLASH, WHICH CAN BE CREATED DURING THE VULCANIZATION OF THE VALVE AND WASHER TO THE SHELL IN THE MAIN ASSEMBLY PROCESS. HOLES (RENTS, MATERIAL SEPARATION) IN THE VALVE POSSIBLY DUE TO A REWORK ACTIVITY, WHICH WAS ELIMINATED. HOLES (RENTS, MATERIAL SEPARATION) IN THE VALVE DUE TO DAMAGE DONE BY VENTING THE DEVICE DURING AUTOCLAVING WHEN SOMETHING OTHER THAN A FILL TUBE IS USED TO VENT THE DEVICE. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE TWO RENTS LEAKAGES WERE FOUND ON THE REPORTED DEVICES. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE LABORATORY EXAMINATION OF THE DEVICE, PE WAS NOT ABLE TO DETERMINE WHEN THE RENT WAS INTRODUCED INTO THE VALVE OF THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE RENT EDGES WAS PERFORMED FOR THE DEVICE (A), AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. 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; HOWEVER, DEFLATION TRENDS FOR MENTOR SALINE-FILLED DEVICES WILL CONTINUE TO BE MONITORED BY QUALITY ASSURANCE. 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 525CC SALINE BREAST PROSTHESIS, CATALOG #3501685, LOT #232246. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC AND A MENTOR SMOOTH ROUND MODERATE PROFILE 525CC SALINE BREAST PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533988 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 233357 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention