MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MM+ 650CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3341505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wrinkling (2613)
Date of Event	04/01/2019
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: wrinkling.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation revision with mentor memoryshape¿650cc silicone breast implants which patient believes her left side is ruptured, and as a result implant has dropped.Her right side has wrinkled and feels like a bubble.These issues occurred after implantation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the right side.
Additional Manufacturer Narrative
Additional information received on september 10, 2024, indicated that the patient underwent bilateral removal on (b)(6) 2024.Reason for device explant and/or reoperation: wrinkling manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on september 9, 2024, indicated that the post-operation indicated that the right implant was rotated and had defect anteriorly.As a result, patient underwent right side with 695cc natrelle scf exchange, liposuction lateral axillary line, fat transfer breast, mesh reinforcement of attenuated capsule.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Suspect device received on october 22, 2024.Device evaluation completed on november 12, 2024: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample determined that the mentor memoryshape¿ mm+ 650ccc breast implant was found to be ruptured.The rupture was found on the anterior view, measuring approximately 3.0 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in an area of the tear, measuring approximately less than 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Wrinkling is reported to occur more frequently in patients with one or more of the following: thin-skinned patients, patients with little or no subcutaneous fat, subglandular rather than submuscular placement, an implant that is too large relative to the breast pocket size or frame of the patient, overlying tissue that is minimal or of poor quality, and/or when capsular contracture is present.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 MEMORYSHAPE¿ MM+ 650CC
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 8691412
• Report Number: 1645337-2019-13700
• Device Sequence Number: 2354621
• Product Code: FTR
• UDI-Device Identifier: 00081317005384
• UDI-Public: 00081317005384
• 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: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/16/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2021
• Device Catalogue Number: 3341505
• Device Lot Number: 7283933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 09/10/2024; 09/11/2024; 10/22/2024
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 09/11/2024; 09/12/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female