MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3507175BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	10/01/2018
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 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: no information regarding explantation or an expected explantation date has been received.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with a 175 cc mentor memorygel breast implant and experienced a rupture and a reaction on the left side post-operatively, which was confirmed via an mri.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On july 10, 2023, mentor received a new date of explant.Relevant fields have been updated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 18, 2023, the mentor failure analysis lab received the device for evaluation.On august 24, 2023, mentor completed evaluation of the device.Device evaluation summary: the product was returned to mentor for evaluation. mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the gel mod-rnd 175cc breast implant had an area of shell abrasion on the posterior view.In addition, an area of separated material was observed on the posterior view extending to the anterior view within the shell abrasion measuring approximately 3.5 x 5.4 cm the evaluation determined that the possible cause of the rupture is consistent with normal wear.Shell abrasion suggests in-vivo folding or creasing of the device.This may be the result of the following factors: continuous and sustained stresses to the device such as too small breast pocket and folding or wrinkling of the shell in the breast pocket.In some cases, the breast implants may also wear out over time.  as part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.  additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12289878
• Report Number: 1645337-2021-08798
• Device Sequence Number: 4599603
• Product Code: FTR
• UDI-Device Identifier: 00081317000044
• UDI-Public: 00081317000044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2021

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: 01/31/2005
• Device Model Number: 3507175BC
• Device Catalogue Number: 3507175BC
• Device Lot Number: 204954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 07/10/2023; 08/18/2023
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 07/31/2023; 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2000
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White