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

Model Number	3541507
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Granuloma (1876); No Code Available (3191)
Date of Event	10/27/2015
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female underwent a primary breast augmentation with 150cc mentor memorygel breast implants and experienced bilateral rupture, device migration and granuloma post-operatively.The ruptures were confirmed with an mri.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the patient's left-sided device.
Additional Manufacturer Narrative
Additional information: on 09/13/2019, mentor became aware of the device's lot number and expiration date.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2019, mentor became aware that the patient¿s date of explant was rescheduled to (b)(6) 2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: on (b)(6) 2019, mentor became aware that the patient is scheduled to undergo bilateral device removal on (b)(6) 2020.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.On 10/15/2019, 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.The manufacturing date was also added.Reason for device explant and/or reoperation: rupture and device migration manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: on (b)(6) 2019, mentor became aware of the correct explantation date.On (b)(6) 2019, 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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On march 4, 2020, the product investigation was completed.Device investigation summary: during visual evaluation of the device, an area of siltex cracking was observed on the posterior view.Within the siltex cracking area, a tear measuring approximately 1 cm was noted.The evaluation determined that the rupture is consistent with the siltex cracking.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices resulting in a tear at a later date.Granulomas are noncancerous nodules that are a common tissue reaction to the presence of a variety of foreign materials, such as silicone.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.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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).

• 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: 9175813
• Report Number: 1645337-2019-21379
• Device Sequence Number: 2775131
• Product Code: FTR
• UDI-Device Identifier: 00081317000617
• UDI-Public: 00081317000617
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/11/2019

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: 11/15/2003
• Device Model Number: 3541507
• Device Catalogue Number: 3541507
• Device Lot Number: 185355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019; 10/10/2019; 11/05/2019; 12/17/2019; 03/04/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/10/2019; 11/01/2019; 11/08/2019; 01/06/2020; 03/04/2020
• 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: Required Intervention
• Patient Age: 46 YR