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

Catalog Number	3542713
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
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.Concomitant products: mentor siltex contour profile high 450cc saline prosthesis, catalog # 3542713, lot # 222021.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent breast augmentation revision with a mentor siltex contour profile high 450cc saline prosthesis right sided deflation and pain post procedure.As a result, the device was explanted on (b)(6) 2019.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 5/9/2019.The analysis has begun but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the finished device number (b)(4) on 5/26/2019, and no non-conformances related to the reported complaint were identified.During evaluation of the sample it was observed to be ruptured.Microscopic examination of the edges of the tear gave no indications as to cause of the failure.No other anomalies were discovered.Deflation is a known complication associated with mentor mammary prostheses.Possible causes of deflation of saline-filled implants include, but are not limited to, the following events: excessive stresses or manipulations as may occur during normal daily routines including customary and purposeful trauma to the breast.The reported complaint was confirmed.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Most women undergoing augmentation or reconstruction with a mammary prosthesis will experience some pain postoperatively.While pain normally subsides in most women as they heal from surgery, it can become a chronic problem in other women.Chronic pain can be associated with a variety of factors.Pain is a known complication associated with these devices and is referenced in our current product insert data sheet.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE HIGH
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8575076
• Report Number: 1645337-2019-10972
• Device Sequence Number: 2386753
• Product Code: FWM
• UDI-Device Identifier: 00081317001928
• UDI-Public: 00081317001928
• Combination Product (Y/N): N
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2005
• Device Catalogue Number: 3542713
• Device Lot Number: 222021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 05/26/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/04/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention