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

Model Number	3542001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	01/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis was completed on a photo received of the suspect medical device.The physical product was not returned to mentor.Device evaluation summary: according to the information reported, the patient developed capsular contracture.During visual evaluation of the picture, no apparent damage or visual anomalies were observed in the product.Mentor concluded that the capsular contracture in the patient's breast was the result of the body's individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Although the product was not received, the manufacturing records of the lot-serial number provided were identified.The manufacturing records were reviewed, and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Capsular contracture complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.Reason for device explant and/or reoperation: bilateral breast capsular contracture.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient who underwent a breast augmentation revision with mentor memorygel breast implant 200cc gel breast prostheses developed baker grade iii capsular contracture in both of her breasts.As a result, the patient underwent bilateral explantation and replacement with unspecified mentor gel breast prostheses on (b)(6) 2020.This medwatch report is for the 2nd of two gel breast prostheses.
Additional Manufacturer Narrative
On 02-dec-2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the patient developed capsular contracture on the breast.During the visual evaluation, a tear in the anterior view was observed measuring approximately 1.3 cm.Mentor concluded that the capsular contracture in the patient¿s breast was the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 02-nov-2020, the mentor failure analysis lab 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.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
• MDR Report Key: 10671509
• Report Number: 1645337-2020-12963
• Device Sequence Number: 14134967
• Product Code: FTR
• UDI-Device Identifier: 00081317000822
• UDI-Public: 00081317000822
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 3542001
• Device Catalogue Number: 3542001
• Device Lot Number: 5997128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 12/02/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/19/2020; 12/04/2020
• 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: Required Intervention
• Patient Age: 30 YR