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

Model Number	3503190
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: mentor smooth round high profile 190cc saline prosthesis, catalog #3503190, serial #(b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old caucasian female underwent primary breast augmentation with a mentor smooth round high profile 190cc saline prosthesis.On (b)(6) 2018 left sided deflation was observed.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
The device history record (dhr) of lot number 5793793 was reviewed on 6/22/2018 and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on april 1, 2020.An explant is scheduled for (b)(6) 2020.2.Is other serious-uncheck 2.Is required intervention-check 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on july 6, 2020.The explant date has rescheduled to (b)(6) 2020.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on september 3, 3030.The investigation of the returned device was completed by the failure analysis lab on september 23, 2020.Device evaluation summary: during the visual evaluation, an anomaly was observed on the anterior extending to the posterior view consistent with a crease/fold.A tear on the anterior aspect measuring approximately 0.2 cm was also observed within the crease/fold.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 deflation at 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2020.In addition to the left sided deflation reported initially, right sided capsular contracture was also noted.When the devices were explanted, bilateral prosthesis replacement with 500cc mentor memorygel breast implants was performed.This report relates to the left prosthesis.See 1645337-2020-13284, for contralateral prosthesis report.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7575955
• Report Number: 1645337-2018-03525
• Device Sequence Number: 2222121
• Product Code: FWM
• UDI-Device Identifier: 00081317001577
• UDI-Public: 00081317001577
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/18/2018

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: 12/31/2011
• Device Model Number: 3503190
• Device Catalogue Number: 3503190
• Device Lot Number: 5793793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018; 04/01/2020; 07/06/2020; 09/03/2020; 10/12/2020
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/10/2018; 04/03/2020; 07/24/2020; 09/23/2020; 11/03/2020
• 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: Other; Required Intervention
• Patient Age: 35 YR