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

Catalog Number	3542713
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
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.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent primary breast augmentation with mentor siltex contour profile high 450cc saline breast prosthesis.Left breast prosthesis deflation was determined.As a result, the patient underwent removal on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2018, 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.On (b)(6) 2018, mentor became aware that the correct suspect medical device's date of implantation was (b)(6) 1996.Mentor also became aware of the following: concomitant products: mentor siltex contour profile high 450cc saline catalog: 3542713.Replacement devices: bilateral removal and replacement with mentor memorygel breast implant 325cc gel, catalog: 3503251bc, lot: 7477007, sn: (b)(4) and mentor memorygel breast implant 350cc gel, catalog: 3503501bc, lot: 7478644, sn: (b)(4).(b)(4).
Additional Manufacturer Narrative
Upon receipt by mentor, the device returned without fluid.Brown material was observed within the device.No foreign material was observed on the shell surface.Product evaluation discovered a rent measuring approximately 0.4 cm on the anterior aspect.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage or the brown material found on the device.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.The 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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 6/19/2018, mentor became aware that the patient experienced no accompanying symptoms, had no medical intervention, and was only in the hospital for the duration of the surgery and was then released after.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: 7515376
• Report Number: 1645337-2018-02916
• Device Sequence Number: 19490361
• Product Code: FWM
• UDI-Device Identifier: 00081317001928
• UDI-Public: 00081317001928
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2018

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 Catalogue Number: 3542713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018; 04/20/2018; 04/20/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/13/2018; 06/19/2018; 06/20/2018
• 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: 47 YR