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

Model Number	3542001
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: upon visual evaluation of the image provided in the complaint, no apparent damage was observed to the implant.As the product involved in this complaint was not received, the device couldn¿t be analyzed according to our procedures.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.As part of mentors quality process all devices are manufactured, inspected, and released to approved specifications.Reason for device explant and/or reoperation: rupture.Manufacturers reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation with a 200cc mentor memorygel breast implant and experienced postoperative left-sided rupture.Ultrasound performed on (b)(6) 2021 indicated the left-sided rupture.As a result, the patient underwent removal and replacement with a 225cc mentor memorygel breast implant (catalog #: 3542251, left serial #: (b)(4) on (b)(6) 2021.
Additional Manufacturer Narrative
On (b)(6) 2021, 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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 1-sept-2021, the investigation on the suspected medical device was completed.Investigation summar: mentor then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned device revealed a tear on the patch.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear, measuring approximately 0.1 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 12194044
• Report Number: 1645337-2021-08106
• Device Sequence Number: 1323491
• Product Code: FTR
• UDI-Device Identifier: 00081317000822
• UDI-Public: 00081317000822
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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: 12/01/2021
• Device Model Number: 3542001
• Device Catalogue Number: 3542001
• Device Lot Number: 7400529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 07/30/2021; 09/01/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/19/2021; 09/05/2021
• 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: 59 YR