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

Model Number 3501635

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 05/01/2020

Event Type  Injury  

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: device migration.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation revision with mentor smooth round moderate profile 250cc saline breast implants which the left side deflated, and bilateral issue with displacements of implants, more on left than right side after implantation.The issue was confirmed by the physician.As a result, patient underwent bilateral removal on (b)(6) 2020.

Manufacturer Narrative

On jul 29, 2020, 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.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Device evaluation completed on (b)(6) 2020: during a visual evaluation, no apparent damage or visual anomalies were observed on the returned device.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.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.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: 10258226
• MDR Text Key: 198346283
• Report Number: 1645337-2020-08476
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 00081317001225
• UDI-Public: 00081317001225
• Combination Product (y/n): N
• PMA/PMN Number: P990075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2019
• Device Model Number: 3501635
• Device Catalogue Number: 3501635
• Device Lot Number: 6924243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR