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

Catalog Number	3341109
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	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: right breast capsular contracture (baker grade iii).Concomitant products: mentor memoryshape breast implant 270cc gel breast prosthesis, catalog #3341109, serial #(b)(4).(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient who underwent a primary breast augmentation procedure with a mentor memoryshape breast implant 270cc gel breast prosthesis developed capsular contracture (baker grade iii) in her right breast.Capsular contracture was noticed by a physician.As a result, the patient will undergo explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On 05/23/2019, the mentor failure analysis lab received the device for evaluation.On 06/06/2019, mentor received additional information about the event.It was initially reported that the patient dob is (b)(6) 1985.New information states that the patient dob is (b)(6) 1985.On 06/12/2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, it was reported that the patient developed capsular contracture.During evaluation of the sample a tear was observed in the anterior view, measurement approximately 12.1 cm.No additional anomalies were observed.Based on the facts of the case, is unrelated to the breast implant and related to the patient condition.The second product received is related to a concomitant device, therefore no further investigation is required.Postoperative formation of a fibrous tissue capsule around a mammary prosthesis is a normal physiologic response to the implantation of a foreign object and occurs in all patients in varying degrees.In some cases, contracture of the fibrous capsule may occur.This phenomenon is referred to as capsular contracture.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.No further investigation will be conducted on this complaint due to external cause.The reported complaint could not be confirmed.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: 8605995
• Report Number: 1645337-2019-11768
• Device Sequence Number: 19588162
• Product Code: FTR
• UDI-Device Identifier: 00081317005056
• UDI-Public: 00081317005056
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Catalogue Number: 3341109
• Device Lot Number: 7302262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: 33 YR