MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542915
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has 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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: breast pain, deflation.Concomitant medical products: (right) 525cc mentor siltex contour profile moderate saline catalog: 3542915 lot: 7288964 sn: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation with two 525cc mentor siltex contour profile moderate saline breast prostheses, suffered left breast implant deflation post-operatively.As a result, the patient underwent bilateral implant explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor became aware that the patient had undergone bilateral replacement with two unspecified saline breast prostheses.On (b)(6) 2020, a manufacturing record evaluation (mre) was performed for the complaint device.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 1/28/2020, the product investigation was completed.Device investigation summary: the device was visually inspected, and it was found with no apparent damage.Leak testing revealed there was leakage from the valve.The analysis was unable to determine the root cause for the leaking valve.Excessive manipulation may have caused the valve leak.The ifu states ¿not to manipulate (i.E., squeeze) the valve excessively, which may cause valve leakage¿.However, this cannot be conclusively determined.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some breast and/or chest pain post-operatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with the compression of nerves, hematoma, migration, infection, surgical technique, improper size, placement or capsular contracture.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.The second product received is related to a concomitant device, therefore no further investigation is required.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9537915
• Report Number: 1645337-2020-00023
• Device Sequence Number: 19401928
• Product Code: FWM
• UDI-Device Identifier: 00081317001898
• UDI-Public: 00081317001898
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 3542915
• Device Catalogue Number: 3542915
• Device Lot Number: 6846622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/14/2020; 01/28/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/16/2020; 01/28/2020
• 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
• Patient Age: 51 YR