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

Model Number	3541757
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/23/2020
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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a revision breast augmentation with two 175cc mentor memorygel breast implant prostheses and experienced right-sided rupture and left-sided cutaneous contour deformity postoperatively.Mri performed on (b)(6) 2020 indicated right-sided rupture.In addition, the healthcare professional reported that a few left folds were observed.The diagnosis was confirmed via physical examination and pre-op scan.At the time of this report, mentor has received no information regarding an expected explantation date.The date of implantation was estimated as (b)(6) 1998 based on available information.This report is for the right-sided prosthesis.
Additional Manufacturer Narrative
On 17-feb-2021, mentor received additional information regarding the revision surgery.The patient is scheduled to undergo bilateral removal and replacement with two 250cc mentor memorygel breast implant prostheses (catalog #: 3502501bc) on (b)(6) 2021.D.6.B explantation date: (b)(6) 2021.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.Updated reason for device explant and/or reoperation: rupture manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 17-mar-2021, mentor received additional information regarding the explantation date and suspected medical device.Previously, the explantation date was reported as on (b)(6) 2021.However, additional information revealed that the actual explantation date was on (b)(6) 2021.The suspected medical device was returned for evaluation.The relevant fields have been updated.On 24-mar-2021, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed no damage or anomalies.Leak testing was performed according to the mentor procedure, and the result revealed a tear within an area of siltex cracking on the posterior view, measuring approximately less than 0.1 cm.The evaluation determined that the cause of the rupture is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On july 22, 2021, mentor received additional information indicating that the correct date of implantation was on (b)(6) 1998.In addition, the patient has fully recovered and more information about the replacement devices were provided.Replacements: (right) lot: 7368588, sn: (b)(6) and (left) lot: 7416898, sn: (b)(6).Manufacturer¿s reference number: (b)(4).This medwatch form is for the right 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: 10971919
• Report Number: 1645337-2020-15624
• Device Sequence Number: 11571724
• Product Code: FTR
• UDI-Device Identifier: 00081317000624
• UDI-Public: 00081317000624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/16/2020

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 Model Number: 3541757
• Device Catalogue Number: 3541757
• Device Lot Number: 159741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 02/17/2021; 03/17/2021; 07/22/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 03/10/2021; 03/25/2021; 07/30/2021
• 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: Other; Required Intervention
• Patient Age: 70 YR