MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542655
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 52-year-old female patient underwent primary breast augmentation with 350cc mentor siltex round moderate profile and experienced breast implant deflation on her left side postoperatively; diagnosed in the office.The patient has consulted with the healthcare professional.As a result, the device was explanted on (b)(6) 2023.
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: left deflation.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).
Additional Manufacturer Narrative
On november 16, 2023, the mentor failure analysis lab received the device for evaluation.Additional information was requested to clarify the impacted lot number, but it was not provided.Consequently, the lot number under field d4 from 5581925 to 5595551, and serial number from (b)(6) to (b)(6) have been updated on this form.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.On december 4, 2023, device evaluation was completed.Device evaluation summary: mentor conducted visual inspection, leak testing and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sal siltex rnd diap pkg 350cc breast implant.Leak testing was performed, according to mentor procedure, and it revealed two tears (a and b) on the posterior view, tear a within an area of siltex cracking, measuring approximately 0.2 cm, and tear b measuring approximately 0.2 cm.Microscopic examination was performed on the edges of the tear b, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, a microscopic examination of the returned product indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation or other surgical procedures.The evaluation determined that the possible cause of the tear a 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.A second product was received (lot-5581925).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 30, 2023, mentor received confirmation that left ruptured implant serial number (b)(6).Right was intact but aspirated by the doctor to find out size of implant serial number (b)(6).Hence, lot and serial number under fields d4 have been updated back to "5581925", and "(b)(6)" respectively.On november 16, 2023, the mentor failure analysis lab received the device for evaluation.When the investigational analysis has been completed for this device, a supplemental report will be submitted.This supplemental medwatch report is for the patient¿s left-sided device.Right side device evaluation results reported under manufacturer report number 1645337-2023-12800 are being reported separately per findings for device with lot number 5595551 under manufacturer report number1645337-2023-14808.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 3, 2024, device evaluation was completed.Device evaluation summary: mentor conducted visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sal siltex rnd diap pkg 350cc breast implant.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the breast implant was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.On november 30, 2023, mentor received confirmation that left ruptured implant serial number (b)(6) right was intact but aspirated by the doctor to find out size of implant serial number (b)(6).Hence, lot and serial number under fields d4 have been updated back to "(b)(6) respectively.On november 16, 2023, the mentor failure analysis lab received the device for evaluation.When the investigational analysis has been completed for this device, a supplemental report will be submitted.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 18117319
• Report Number: 1645337-2023-12800
• Device Sequence Number: 15174523
• Product Code: FWM
• UDI-Device Identifier: 00081317001805
• UDI-Public: 00081317001805
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 01/26/2009
• Device Catalogue Number: 3542655
• Device Lot Number: 5581925
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 11/30/2023; 01/03/2024
• Initial Report FDA Received Date: 11/12/2023
• Supplement Report FDA Received Date: 12/04/2023; 12/18/2023; 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2005
• 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: 52 YR
• Patient Sex: Female