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

Model Number 3501655

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Fatigue (1849); Pain (1994); No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

The mentor failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a 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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation.The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness.The patient underwent explantation procedure on (b)(6) 2016.It was reported that the inside of the valve and the outside of the implant had mold.The implants were intact upon explantation.The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation.

Manufacturer Narrative

On 12/20/2018, mentor received a request for additional information regarding this complaint from fda.On 1/2/2019, an extension was granted until 2/16/2019."response to fda regarding report number 1645337-2017-00125" - mentor's response to fda's inquiry.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Device evaluation summary: it was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor saline smooth round moderate profile implants 350cc (catalog # 3501655) reported multiple symptoms that began right after implantation.The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness.The patient underwent explantation procedure in (b)(6) 2016.It was reported that the inside of the valve and the outside of the implant had mold.The implants were intact upon explantation.The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation.A visual inspection of the returned complaint device was completed by the product analysis laboratory on (b)(4) 2017.It was noted that a black, brown foreign material was present on the valve of the implant.It was also noted that a brown foreign material was present on the shell surface.Microbial testing/foreign matter identification: no microbial testing and/or foreign matter identification was performed since the implant has been decontaminated per the return instructions and the implant experienced uncontrolled handling and storage conditions.Upon explantation, the implant was decontaminated per mentor¿s instructions.Then, 14 months elapsed between the time of explantation and when mentor received and the mentor product analysis laboratory analyzed the implant.The storage conditions of the device are unknown for this 14-month period.Due to these factors, the laboratory did not perform any analysis of any biological matter on the devices because it concluded the results of the foreign matter testing/identification may not reflect what was reported by the customer and would most likely confound any analysis.A leak test was performed in accordance with mentor procedures, and no leak was identified on the device (including the valve) which could have contributed to the foreign matter in question.The fill valve of the returned device was visually inspected, and no visible damage was noted.Root cause investigation: a cause and effect analysis was completed to assist in identifying the root cause of the foreign matter on the returned device.The following potential root causes were identified and analyzed.Mentor reviewed the instructions for use and product insert data sheet, which contain the following information: sterilization: siltex® texture and smooth-surface saline-filled breast implants are provided sterile.They are sterilized by either gamma radiation or dry heat.The exact method can be determined by the sterilization symbol on the outer packaging.This product is for single use only.Do not resterilize.Testing procedure for saline-filled implants: the device should be tested for patency and shell integrity immediately prior to use.This can be accomplished by the following steps: partially inflate the prosthesis with air through the fill tube, taking care not to damage the valve.Submerge the air-filled prosthesis in sterile, pyrogen-free testing fluid (water or saline).Apply mild pressure and check for possible punctures or leaks.Filling the implant: use a syringe filled with sterile, pyrogen-free sodium chloride u.S.P.Solution for injection to fill the prosthesis to the recommended volume (see specifications on product labeling).Only sterile, pyrogen-free sodium chloride u.S.P.Solution for injection drawn from its original container should be used.As it is known that bacterial infections may result from contaminated saline, it is recommended that a new sterile saline container be used with each surgery and implant-filling procedure.As it cannot be conclusively ruled out that the saline injected into the implant or the syringe in the implant was definitively sterile and pyrogen-free, ¿man¿ is considered a potential root cause for the foreign matter on the valve of the implant.Machine/material/method/measurements (manufacturing) the manufacturing record evaluation (mre) was reviewed for product code 3501655, lot# 5548928 and no anomalies were identified which would result in foreign matter on device, specifically the valve and shell surface.The product was within specification and was manufactured and sterilized in accordance with procedures.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 are controlled manufacturing environments (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 review for product code- 3501655, lot#- 5548928.The lot was sterilized on (sterile load) (b)(4) on (b)(6) 2004 at the (b)(4).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- 3501655, lot#- 5548928 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- 3501655, lot#- 5548928) were reviewed and no excursions were identified.As a result of the cumulation of the above-mentioned items, manufacturing was ruled out as a potential root cause.Mother nature: mother nature was ruled out as a potential root cause since the mentor device is manufactured in a controlled and monitored environment and sealed in a sterile package container when shipped to the customer.Based on the root cause investigation conducted, the most probable root cause for the foreign matter on the valve and shell of the implant is caused by the saline and syringe not being sterile and pyrogen-free at the point of implantation.There is no evidence that the issue is related with manufacturing.Instructions via the product insert data sheet are provided to ensure proper technique is used when injecting saline into the implant to prevent contamination.In addition, the application failure modes and effects analysis (afmea) was reviewed for the defect in question and the hazard risk was determined to be as low as possible, with no further action required.Foreign matter trends for mentor saline-filled devices will continue to be monitored by quality assurance.Per mentor procedure, all returned mentor complaint devices are shipped to the product analysis laboratory to be decontaminated and then a complaint evaluation/investigation is completed.As a result of process improvements, updates were made in september 2018 to mentor procedures in which foreign matter process flow charts were created to provide the product analysis laboratories further instructions on how to handle and process reported foreign matter on devices associated with complaints.These updates are in place to further ensure complaints for reported foreign in matter are consistently and properly investigated and addressed in a timely matter.In addition, an internal corrective action was initiated to investigate the lack of standard work to investigate foreign matter at the time this complaint was reported and other improvements that can be made to the mentor product analysis lab processes.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: joaquin kurz ; 3041 skyway circle north; irving, TX 75038 ; 949789-383
• MDR Report Key: 6983886
• MDR Text Key: 90438787
• Report Number: 1645337-2017-00125
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 00081317001263
• UDI-Public: (01)00081317001263(11)040816(17)080813(10)5548928
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2008
• Device Model Number: 3501655
• Device Catalogue Number: 3501655
• Device Lot Number: 5548928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR