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

Model Number	3542625
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent breast augmentation revision with two 200cc mentor siltex round moderate profile saline breast prostheses.Post-operatively, the patient was physically diagnosed with right breast implant deflation.It was indicated that the deflation was right after a mammogram.As a result, the patient underwent implant removal on (b)(6) 2022.
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: material rupture after mammogram.Manufacturer¿s reference number: (b)(4).
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: material rupture after mammogram.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent breast augmentation revision with two 200cc mentor siltex round moderate profile saline breast prostheses.Post-operatively, the patient was physically diagnosed with right breast implant deflation.It was indicated that the deflation was right after a mammogram.As a result, the patient underwent implant removal on (b)(6) 2022.
Additional Manufacturer Narrative
On march 21, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the sal siltex rnd diap pkg 200cc breast implant had a tear on the posterior view, measuring approximately 0.5 cm.The evaluation determined that the cause of the deflation is the trauma experienced.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Trauma is a known inherent risk of the saline-filled mammary prosthesis.A second product was received (5543685).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
On february 28, 2022, mentor became aware that the patient underwent bilateral removal and replacement with the following devices: (right) 125cc mentor smooth round moderate profile saline catalog: 3501610 lot: 9665537 sn: (b)(6) and (left) 125cc mentor smooth round moderate profile saline catalog: 3501610 lot: 9665537 sn: (b)(6) 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 march 10, 2022, the mentor failure analysis lab 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.

• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13552307
• Report Number: 1645337-2022-01765
• Device Sequence Number: 5199493
• Product Code: FWM
• UDI-Device Identifier: 00081317001744
• UDI-Public: 00081317001744
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2022
• 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: 03/15/2008
• Device Model Number: 3542625
• Device Catalogue Number: 3542625
• Device Lot Number: 5528390
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 03/21/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/20/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2004
• 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: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White