MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND HIGH PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3503420
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Capsular Contracture (1761); Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Hypoesthesia (2352); Cognitive Changes (2551); No Code Available (3191)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) review is in progress.A supplemental report will be submitted upon its completion.Manufacturer's ref.No:(b)(4).
Event or Problem Description
It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants.The patient underwent implantation on (b)(6) 2007.Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues.Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure.There was no previous history of autoimmune disease.Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature.Visual contrast sensitivity and human beta growth factor tests were administered.Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015.Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation.No extended hospitalization was required.Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity.
Additional Manufacturer Narrative
On 11/6/2017, a device history record (dhr) review was performed for this device.As a result, the manufacturing date, expiration date and udi fields have been updated.The device history record (dhr) of lot number 5748581 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.(b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the manufacturing record evaluation (mre) of lot number 5748581 was reviewed and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.In addition, no related complaints have been reported for this lot number.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Manufacturing controls: the manufacturing process (from shell fabrication to secondary packaging) was reviewed for foreign matter/ particulate control at mentor irving cmes (controlled manufacturing environment) which includes shell fabrication, main assembly, primary packaging areas, gamma sterilization, and secondary packaging areas.At multiple points of the manufacturing process, devices within the lot are processed to ensure any foreign matter, particulates or contaminants are removed or 100% visually inspected for any defects including foreign matter or particulates and subsequently rejected when identified.All manufacturing areas where the shell or device is exposed to environment is a controlled manufacturing environment (cme).Gowning is required and strictly enforced for all individuals entering designated controlled manufacturing environments (cme) at mentor, whether they are mentor employees, visitors or contractors.The cme garments consist of hair coverings (bouffant and/or hood), frock or jumpsuit, and shoe or boot covers.Sterilization records were also reviewed for product code, lot#- 5748581.The lot was sterilized on (sterile load) (b)(4) on (b)(6) 2004 at the (b)(6).No anomalies were noted and all parameters were within specification.Environmental monitoring for viable airborne particulates and surface microbials is routinely performed in each controlled manufacturing environment (cme) on a weekly basis.Review of the environmental monitoring data for viable airborne particulates and surface microbials during the manufacturing of product code, lot#- 5748581 identified all acceptable results in order to release the lot.Non-viable particulates are measured on a quarterly basis.Review of the non-viable particulates data for q204 and q304 (periods before and after the manufacture of product code, lot#- 5748581) were reviewed and no excursions were identified.A root cause failure analysis will not be conducted since the investigation could not confirm that an actual failure of the device to conform to expected performance had occurred.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.Infection is a known complication associated with any surgery.The application failure modes and effects analysis (afmea) was reviewed for the defect in question (foreign matter/mold) with the hazard risk was determined to be as low as possible (alap), with no further action required.If the complaint device is received in the future, the complaint will be re-opened and additional investigation will be completed.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7001971
• Report Number: 1645337-2017-00134
• Device Sequence Number: 1090455
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: 3503420
• Device Lot Number: 5748581
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017; 02/28/2019
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 11/07/2017; 03/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention