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

Catalog Number	3341405G
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Granuloma (1876)
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 was performed for the finished device 7369543 number, and no non-conformances were identified.Manufacturing date: 24/aug/2016, expiration date: 26/aug/2021.A manufacturing record evaluation was performed for the finished device 6868107 number, and no non-conformances were identified.Manufacturing date: 14/oct/2014, expiration date: 13/oct/2019, mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient who had a 525cc mentor memoryshape breast implant placed experienced unilateral rupture with granuloma formation post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Two lot and serial numbers were provided, however, the one belonging to the event could not be determined.This is reflected in section d.
Additional Manufacturer Narrative
Additional information was received on november 27, 2023.Explant is scheduled for (b)(6) 2023.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.Reason for device explant and/or reoperation: granuloma/rupture manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on march 14, 2024.The investigation of the returned device was completed by the failure analysis lab on march 21, 2024.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the breast implant was found to be ruptured.A microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.The following things may cause the implant to rupture: damage by surgical instruments; stressing the implant during implantation and weakening it; folding or wrinkling of the implant shell; excessive force to the chest (e.G.During closed capsulotomy); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on february 9, 2024.The rupture and granuloma issue was clarified to be right sided, lot 6868107, serial (b)(6).In addition to the right sided issues, the patient also experienced bilateral ptosis.This report relates to the right prosthesis.See 1645337-2024-02613 for contralateral prosthesis report.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on january 11, 2024.The explant date was clarified to be on (b)(6) 2024.Replacement with mentor gel boost was performed with explant.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18061744
• Report Number: 1645337-2023-13042
• Device Sequence Number: 15100855
• Product Code: FTR
• UDI-Device Identifier: 00081317005360
• UDI-Public: 00081317005360
• 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: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: 10/13/2019
• Device Catalogue Number: 3341405G
• Device Lot Number: 6868107
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/11/2024; 02/09/2024; 03/14/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/20/2023; 01/31/2024; 03/01/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2014
• 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: Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG