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

Model Number	3541508
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/07/2020
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: seroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female underwent breast augmentation with 530cc mentor memoryshape breast implants and experienced bilateral seroma postoperatively.As a result, the patient underwent bilateral drainage on (b)(6) 2020.This report is for the patient's left-sided device.
Additional Manufacturer Narrative
Additional information: on (b)(6) 2021, mentor became aware that the patient also experienced rupture on the left side.As a result, the patient underwent unilateral device removal and replacement with a 680cc mentor memorygel breast implant, catalog number 3341509, serial number (b)(6), on the left side on (b)(6) 2021.Mentor also became aware of the correct date of birth, the patient identifier and the patient's age at the time of event.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.Reason for device explant and/or reoperation: rupture.This report is for the patient's left-sided device.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: on april 29, 2021, mentor became aware that the patient also experienced device migration on the left side.On may 5, 2021, 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.This report is for the patient's left-sided device.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On june 1, 2021, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection and microscopic examination of the returned device.During the visual evaluation of the mentor memoryshape¿ mm 530cc, a tear was observed in the anterior view measuring approximately 8.1 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear, measuring approximately 0.2 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause of the rupture in the remaining area of the tear could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Implant displacement/migration may occur from improper implant sizing and/or placement, i.E., when the implant is too large or the pocket too small or when there has been inadequate preoperative assessment of stresses causing movement of the prosthesis.Implant displacement/migration is a known complication associated with these devices and is referenced in our current product insert data sheet.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.Possibility of bia-alcl is considered when a patient presents with late onset, persistent peri-implant seroma.In some cases, patients presented with capsular contracture or masses adjacent to the breast implant.When testing for bia-alcl, collect fresh seroma fluid and representative portions of the capsule, and sent to a laboratory with appropriate expertise for pathology test to rule out alcl, including immunohistochemistry testing for cd30 and alk (anaplastic lymphoma kinase).If your patient is diagnosed with peri-implant bia-alcl, develop an individualized treatment plan in coordination with a multidisciplinary care team.The national comprehensive cancer network (nccn) recommends surgical treatment that includes implant removal and complete capsulectomy ipsilaterally as well as contralaterally, where applicable.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This report is for the patient's left-sided device.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: 11136415
• Report Number: 1645337-2021-00232
• Device Sequence Number: 3859082
• Product Code: FTR
• UDI-Device Identifier: 00081317005513
• UDI-Public: 00081317005513
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 3541508
• Device Catalogue Number: 3541508
• Device Lot Number: 7429087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 03/25/2021; 04/29/2021; 06/01/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/14/2021; 05/27/2021; 06/08/2021
• 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: 38 YR