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

Catalog Number	3341509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: seroma.Concomitant medical products: right side: mentor memorygel breast implant, catalog number: 3341509; serial number: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) patient who underwent primary breast reconstruction with mentor gel implants on (b)(6) 2016 developed right breast swelling.The patient had a late seroma in the right breast and rupture per mri on (b)(6) 2019.The patient underwent drainage, partial capsulectomy, explantation and replacement with non mentor implants on (b)(6) 2019.Upon explantation, it was noted that the device was not ruptured.The seroma fluid was tested and returned negative for alcl.Should additional information become available, this case will be re-assessed and notes will be updated.
Additional Manufacturer Narrative
On 6/7/2019, device evaluation was completed: device evaluation summary: during evaluation of the sample it was observed to be intact.No additional anomalies were observed.Based on the facts of the case, is unrelated to the breast implant and related to the patient condition.Excessive postoperative accumulation and/or transient reaccumulation of fluid around an implant most likely occur soon after surgery; however, it can occur at any time.Symptoms from seroma may include swelling, pain, and bruising.While the body absorbs small hematomas and seromas, some will require surgery.Seromas presenting after the immediate post-operative period may require additional work-up by the surgeon.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).
Additional Manufacturer Narrative
On 5/7/2019, mentor became aware that manufacturing record evaluation was completed and initial report was mistakenly submitted as it was not completed.Also, manufacturing and expiration dates submitted under initial were incorrect.On 5/6/2019.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.  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: 8588621
• Report Number: 1645337-2019-11123
• Device Sequence Number: 2191623
• Product Code: FTR
• UDI-Device Identifier: 00081317005131
• UDI-Public: 00081317005131
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2019

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: 04/27/2020
• Device Catalogue Number: 3341509
• Device Lot Number: 6928251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 06/07/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/07/2019; 06/10/2019
• 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: 48 YR