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

Model Number	3341354
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Wrinkling (2613); No Code Available (3191)
Date of Event	09/09/2020
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, cutaneous contour deformity.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a revision breast reconstruction with a 610cc mentor memoryshape breast implant and experienced postoperative left-sided rupture and cutaneous contour deformity.A healthcare professional reported that the patient experienced radiation fibrosis, excess skin, and lipodystrophy.The patient had a consultation with a healthcare professional, and the diagnosis was confirmed via physical examination.As a result, the patient is scheduled to undergo bilateral removal and replacement with unspecified mentor gel breast implants on (b)(6) 2020.
Additional Manufacturer Narrative
On 11-nov-2020, the investigation on the suspected medical device was completed.Investigation summary: during visual evaluation of the device, no apparent damage or anomalies were observed.Leak testing was performed in accordance with the mentor procedures, and no leak sites were detected.After a thorough analysis, mentor was not able to confirm the reported event.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 16-oct-2020, mentor received additional information regarding the diagnosis of left-sided rupture.On 9-sep-2020, the patient's physician stated that a body scan performed on unspecified date indicated left-sided rupture.On 27-oct-2020, 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.On 29-oct-2020, it was found that incorrect brand name was entered in d.1.Brand name on the initial report.The brand name is mentor memoryshape breast implant.The relevant field has been updated.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: 10671167
• Report Number: 1645337-2020-12883
• Device Sequence Number: 2727445
• Product Code: FTR
• UDI-Device Identifier: 00081317024255
• UDI-Public: 00081317024255
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/22/2020

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: 05/30/2023
• Device Model Number: 3341354
• Device Catalogue Number: 3341354
• Device Lot Number: 7579217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 11/11/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/05/2020; 11/12/2020
• 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: 66 YR