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

Catalog Number	354-2757G
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient involved in a clinical trial underwent a primary breast augmentation surgery with implantation of a 275cc mentor clinical gel sltx prosthesis.Post-operatively, the patient was diagnosed with a ruptured left breast implant during an in-office exam with a medical professional.As a result, the patient underwent breast implant removal on (b)(6) 2024.
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.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.Reason for device explant and/or reoperation: rupture manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 09, 2024, mentor was notified that the explantation surgery was cancelled and rescheduled for (b)(6) 2024.Date of explantation: september 09, 2024 manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 06, 2024, mentor was notified that the patient underwent bilateral removal and replacement with 275cc (left-sided) and 325cc (right-sided) mentor memorygel breast implants on (b)(6) 2024.Date of explantation: (b)(6) 2024 on august 20, 2024, the mentor analysis lab received the suspect medical device for evaluation.D4: udi: (01)gtin unavailable, product made prior to gtin compliance date.On august 26, 2024, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.Visual analysis of the returned sample revealed that the breast implant had a tear within an area of siltex cracking on the posterior view, measuring approximately 2.0 cm.The evaluation determined that the possible 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: CLINICAL GEL SLTX
• 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: 19480730
• Report Number: 1645337-2024-06881
• Device Sequence Number: 18177497
• Product Code: FTR
• UDI-Device Identifier: 00081317000662
• UDI-Public: 00081317000662
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 05/31/2005
• Device Catalogue Number: 354-2757G
• Device Lot Number: 217004
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 08/06/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/24/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2000
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White