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

Model Number	3546001
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	04/19/2018
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: capsular contracture.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast augmentation primary with a mentor memorygel breast implant 600cc and experienced capsular contracture baker grade iii the left breast implant.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2020, it was reported to mentor that the date of removal will be (b)(6) 2020.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 8/19/2020, it was reported to mentor that the date of removal was (b)(6) 2020.The replacement device was mentor memorygel breast implant 650cc.On (b)(6) 2020, it was reported to mentor that the capsular contracture on the left side was baker grade iii/iv.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the mentor failure analysis lab has received the device for evaluation.On (b)(6) 2020, it was reported to mentor that the capsular contracture was baker grade iv.The customer was dissatisfied with the implant.On 9/18/2020, during a visual evaluation no apparent damage or visual anomalies were observed on the returned device.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.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.A second product was received (7292949).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.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.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: capsular contracture mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.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: 8737903
• Report Number: 1645337-2019-14442
• Device Sequence Number: 11396624
• Product Code: FTR
• UDI-Device Identifier: 00081317000945
• UDI-Public: 00081317000945
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 3546001
• Device Catalogue Number: 3546001
• Device Lot Number: 6974344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/17/2020; 08/19/2020; 09/09/2020
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/22/2020; 08/21/2020; 09/20/2020
• 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
• Patient Age: 42 YR