CE MED HEIGHT TE 450CC

Additional Manufacturer Narrative

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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A (B)(4) UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A CE MED HEIGHT TE 450CC TISSUE EXPANDER AND EXPERIENCED LEFT DEFLATION POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2018. NO OTHER ISSUES WERE NOTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 7322022 WAS REVIEWED ON 6/6/2018 AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 6/6/2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE INVESTIGATION OF THE RETURNED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 6/22/2018. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD EUROPEAN UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A CE MED HEIGHT TE 450CC TISSUE EXPANDER AND EXPERIENCED LEFT DEFLATION POST PROCEDURE. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED FLUID WITH CLEAR APPEARANCE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. GREEN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION, THE PRODUCT EVALUATION TEAM OBSERVED THAT THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND REVEALED ONE LEAKAGE SITE; A RENT AT THE SHELL TO PATCH JUNCTION. MICROSCOPIC EXAMINATION OF THE RENT EDGES GAVE NO INDICATION AS TO ITS CAUSE. NO OTHER ANOMALIES WERE FOUND. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT 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. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE RENT EDGES WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. NO CORRECTIVE ACTION IS REQUIRED SINCE THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. 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).