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

Model Number	3542911
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/01/2019
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 manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.Concomitant medical products: mentor siltex contour profile moderate 225cc, catalog# 3542911, lot# 244693.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast augmentation with a mentor siltex contour profile moderate 225cc and experienced a deflation on the left side post-operatively, which was confirmed by a physician.As a result, the patient underwent explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On march 24, 2020, the mentor failure analysis lab received the device for evaluation.On march 27, 2020, mentor completed evaluation of the device.Device evaluation summary: during visual inspection of the device, an area of siltex cracking was observed in the posterior view.Within the siltex cracking, a tear was noted, measuring approximately 0.7 cm, causing a deflation.The evaluation determined that the rupture is consistent with a siltex cracking deflation.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 in the shell of siltex breast implants.No further investigation will be conducted on this complaint as there are no indication that the issue found is related to the manufacturing process.It is most likely that the siltex cracking was created due of high stresses caused by acute folds which resulting in a tear at a later date.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9721724
• Report Number: 1645337-2020-02508
• Device Sequence Number: 19650938
• Product Code: FWM
• UDI-Device Identifier: 00081317001850
• UDI-Public: 00081317001850
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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 Model Number: 3542911
• Device Catalogue Number: 3542911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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: 48 YR