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

Model Number 3501635

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

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 (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: deflation.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 after implantation.The issue was confirmed by the physician.As a result patient underwent bilateral removal on (b)(6) 2020.

Manufacturer Narrative

On (b)(6) 2020 additional information received indicates that patient also had bilateral displacements of implants, greater for left than right.This report is for the left side.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Device evaluation completed on july 31 2020: during the visual evaluation, an anomaly was observed on both views of the device, consistent with a crease/fold.Leak testing was performed, according with mentor procedure, and it revealed a tear within the crease/fold on the posterior view, measuring approximately 0.3 cm.No additional tears were observed.The evaluation determined that the loss of shell integrity is consistent with a crease fold deflation of the implant shell, which is a known inherent risk of saline-filled mammary prosthesis.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in a deflation in a later time.Breast implants may also simply wear out over time.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 breast implants are not considered lifetime devices and deflation/rupture is a known complication associated with these devices and is referenced in our product insert data sheet.  manufacturing date: 08/21/2015.(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: 10141036
• MDR Text Key: 194758352
• Report Number: 1645337-2020-07200
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: 3501635
• Device Catalogue Number: 3501635
• Device Lot Number: 6962126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR