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

Catalog Number 3501660

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546)

Patient Problems Ptosis (2620); No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

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 manufacturing record evaluation (mre)) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: left-mentor smooth round moderate profile 375cc saline breast implants, catalog number 3501660 , serial number (b)(4).Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a (b)(6) year-old female patient underwent a primary breast augmentation with mentor smooth round moderate profile 375cc saline breast implants which the right side deflated after implantation.Patient reported the right side is lower and tender.Patient noticed on (b)(6) 2019 and doctor confirmed deflation on (b)(6) 2018.As a result patient scheduled for removal on (b)(6) 2019.

Manufacturer Narrative

Additional information received on 5/7/2019, indicated that the surgery postponed to another month.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 8/6/2019, suspect device was received.On 8/8/2019,additional information received indicated that the patient underwent bilateral removal and replacement as follow:left replaced with catalog number 3504254bc serial number (b)(4), and right replaced with catalog number 3504254bc serial number (b)(4) on (b)(6) 2019.The op- report also indicated that the right implant migrated.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Device evaluation: during visual evaluation a crease was observed in the anterior view.Leak testing revealed a tear within the crease measuring approximately 0.1 cm.No other anomalies were observed.The second product received is related to a concomitant device, there are neither deficiencies alleged nor patient injuries.Therefore no further investigation is required.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.Some breast ptosis is a normal component of the mature breast.Ptosis becomes undesirable when the breast parenchyma predominates below the areola, droops considerably below the inframammary fold and the nipple points downward.Augmentation alone, without consideration of the ptosis can produce a less than desirable cosmetic result known as a "rock in sock" deformity or an increased ptotic appearance.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.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8529205
• MDR Text Key: 142412650
• Report Number: 1645337-2019-10343
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 00081317001270
• UDI-Public: 00081317001270
• Combination Product (y/n): N
• PMA/PMN Number: P990075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 3501660
• Device Lot Number: 6603684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Date Manufacturer Received: 09/04/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR