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

Model Number	3542911
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/18/2019
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 (mre) was performed, 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.Reason for device explant and/or reoperation: misshapen breast, device migration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient who underwent a breast augmentation revision with two 225cc textured mentor siltex contour profile moderate saline breast implant has experienced postoperative right-sided deflation of implant and left-sided misshapen breast.The patient¿s right breast has become smaller.Her left breast has fullness in the medial upper pole, and flattening in the lower lateral pole, and the patient reported she can feel the edge of the left implant; healthcare professional stated that this is consistent with this contour implant rotating to what appears to be upside down.As a result, the patient underwent explantation and replacement with 325cc mentor smooth round moderate plus profile saline breast implants, catalog # 3502325, left serial # (b)(4) and right serial # (b)(4) on (b)(6) 2020.Upon explantation, the right implant was confirmed to be deflated and had rotated sideways, and the left implant was confirmed to be rotated.This medwatch report is for the left-sided implant.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, it was reported that the patient experienced device migration.During visual inspection of the device no apparent damage could be observed.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.An investigation of the returned device was performed, and mentor could not uncover any device failure that we could connect to the reported medical symptoms, however complaint information will be included in complaint trending that is reviewed by quality assurance to determine if further action is necessary.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: 9781499
• Report Number: 1645337-2020-03514
• Device Sequence Number: 19447032
• Product Code: FWM
• UDI-Device Identifier: 00081317001850
• UDI-Public: 00081317001850
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 08/31/2015
• Device Model Number: 3542911
• Device Catalogue Number: 3542911
• Device Lot Number: 6503086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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: 55 YR