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

Catalog Number	3543607MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	07/12/2019
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 (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: rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient who underwent primary breast augmentation with two 360cc mentor memorygel breast implants, suffered bilateral rupture post-operatively.As a result, the patient was scheduled for bilateral implant explantation on (b)(6) 2019.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
On 9/25/2019, the product investigation was completed.Device investigation summary: during evaluation of the sample it appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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 condition has also been associated with device deflation/ rupture, wrinkling and/or displacement of the prosthesis.Capsular contracture may be more common following infection, hematoma, and seroma, and the chance of it happening may increase over time.It should be noted that as part of our quality process, 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
On 8/29/2019, mentor became aware that the patient only suffered left side rupture, instead of the bilateral rupture initially reported.Mentor also became aware that the patient also suffered left side capsular contracture; baker grade unknown, post-operatively.Mentor also became aware that the patient had undergone bilateral removal and replacement with two unspecified mentor gel implants.On 9/12/2019, the mentor failure analysis lab has 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.Reason for device explant and/or reoperation: capsular contracture.Manufacturer¿s reference number: (b)(4).This medwatch form is for the left breast prosthesis.

• 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: 8912145
• Report Number: 1645337-2019-17512
• Device Sequence Number: 286079
• Product Code: FTR
• UDI-Device Identifier: 00081317004424
• UDI-Public: 00081317004424
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• 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,Followup
• Report Date (Section B): 07/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: 3543607MC
• Device Lot Number: 7287222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/29/2019; 09/25/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/24/2019; 10/17/2019
• 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: 54 YR