MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3541757
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/17/2019
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: rupture.Concomitant medical products: 125cc mentor siltex round moderate profile memory gel breast implant, catalog: 3541257, lot: unknown, serial number: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent primary breast augmentation surgery with a 175cc mentor memorygel breast implant experienced right sided silent rupture post procedure.As a result, patient had undergone removal and replacement with a 295cc mentor memorygel breast implant (left) and a 325cc mentor memorygel breast implant (right) on (b)(6) 2019.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 11/8/2019.Device evaluation summary: according with the information reported the patient experienced a rupture in the breast implant.During evaluation of the device it was observed a paralell lines of shell wear in anterior view, additionally a tear within the shell wear was noted, measuring approximately 1.0 cm.No other anomalies were observed.A fold or wrinkle rupture is a known inherent risk associated with the use of gel-filled mammary prostheses, and may be the result of one or more of the following contributing factors: continuous and sustained stresses to the device - such as too small a breast pocket and folding or wrinkling of the shell in the breast pocket.As stated in the product insert data sheet, creating wrinkles or folds should be avoided during implantation or other procedures as it can result in rupture in a later time.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 10/29/2019, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9202649
• Report Number: 1645337-2019-21941
• Device Sequence Number: 2950996
• Product Code: FTR
• UDI-Device Identifier: 00081317000624
• UDI-Public: 00081317000624
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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: 10/31/2007
• Device Catalogue Number: 3541757
• Device Lot Number: 253134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 11/08/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 10/30/2019; 11/15/2019
• 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: 38 YR