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

Catalog Number	3501420
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2019
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: left side deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent revision breast augmentation with a 175cc mentor smooth round spectrum.The patient noticed a change of fullness of the left breast.Left breast deflation was confirmed via mammogram performed on (b)(6) 2019.As a result, the device was explanted on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor became aware that the replacement device used is: catalog number: 3501420 serial number: (b)(4).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the analysis results showed a crease in the anterior aspect.Leak testing revealed there was leakage within the crease measuring approximately less than 0.1 cm.No additional anomalies were observed.These kind of findings are consistent with a crease/fold failure which is a known inherent risk associated with the use of saline-filled mammary prostheses and may be the result of one or more of the following contributing factors: underinflation or overinflation of the device, 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.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.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8708408
• Report Number: 1645337-2019-14036
• Device Sequence Number: 11223852
• Product Code: FWM
• UDI-Device Identifier: 00081317001966
• UDI-Public: 00081317001966
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 05/23/2019

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: 11/14/2018
• Device Catalogue Number: 3501420
• Device Lot Number: 6882516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 07/22/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/18/2019; 07/22/2019
• 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: 62 YR