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

Catalog Number	3542610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	11/09/2018
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) patient underwent a primary breast augmentation procedure with a mentor siltex round moderate profile 125cc saline breast prosthesis that deflated after implantation.Deflation was on the patient¿s right side.In addition, the patient developed capsular contracture (baker grade i) in her right breast.As a result, the patient underwent explantation and replacement with a mentor memorygel breast implant 175cc gel breast prosthesis on (b)(6) 2018.
Additional Manufacturer Narrative
On 02/15/2019, mentor completed the investigation on the suspect medical device.Upon receipt by mentor, the device contained no fluid.Yellow material was observed on the shell surface.During initial evaluation a rent was observed on the posterior aspect, measuring approximately 1.6 cm, however microscopic examination of the edges of the rent gave no indications of instrument damage.Deflation complaint was confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.At this time is not possible to determine the origin of the yellow material observed.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; however, deflation trends for mentor saline-filled devices will continue to be monitored by quality assurance.A complaint of capsular contracture in the breast was reported.With the information provided, the product evaluation (pe) team concluded the reported complaint of capsular contracture in the patient was the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture and deflation are known complications associated with these devices and are referenced in our current product insert data sheet.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 02/04/2019, the mentor product analysis lab 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.(b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, 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 reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8147747
• Report Number: 1645337-2018-07300
• Device Sequence Number: 2069843
• Product Code: FWM
• UDI-Device Identifier: 00081317001713
• UDI-Public: 00081317001713
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/24/2018

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 Expiration Date: 08/31/2007
• Device Catalogue Number: 3542610
• Device Lot Number: 266006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 11/24/2018
• Supplement Date Received by Manufacturer: 01/07/2019; 02/04/2019; 02/15/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/14/2019; 02/11/2019; 02/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR