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

Catalog Number	3542620
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	07/22/2018
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.The device history record (dhr) was reviewed on 8/14/2018, 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).
Event or Problem Description
It was reported that a (b)(6) female patient underwent primary breast augmentation with a mentor siltex round moderate profile 175 cc saline prosthesis.Deflation on the left breast prosthesis and capsular contracture baker grade iii were diagnosed post procedure via self-examination and then confirmed through a physical examination.As a result, the patient underwent unilateral removal and replacement with a mentor memorygel breast implant 150 cc gel prosthesis on (b)(6) 2018; catalog # 3501501bc, s/ns (b)(4).
Additional Manufacturer Narrative
On 2/4/2019, the mentor failure 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained no fluid.Red material was observed within the device and brown material was observed on the shell surface.During initial evaluation a rent within siltex cracking was observed on the posterior aspect, measuring approximately 0.5 cm.No other anomalies were observed.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.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Mentor believes that siltex cracking is ultimately a result of high stresses caused by acute folds (i.E., severe ¿v¿ or tight folds) in the room temperature vulcanization (rtv) shell of siltex breast implants.At this time is not possible to determine the origin of the brown and red materials 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.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.(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: 7790245
• Report Number: 1645337-2018-04985
• Device Sequence Number: 1808809
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• 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: 1997
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2018

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: 3542620
• Device Lot Number: 153590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 02/04/2019; 03/21/2019
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 02/25/2019; 03/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR