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

Catalog Number	3542615
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/29/2009
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 (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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient who underwent a revision breast augmentation with a 150cc mentor siltex round moderate profile (right) and a 250cc mentor siltex round moderate profile (left) for poland syndrome experienced postoperative bilateral deflation.It was diagnosed by a physician.As a result, the patient is scheduled to undergo explantation on (b)(6) 2019.This report is for the right prosthesis.
Additional Manufacturer Narrative
On 11/15/19, the investigation on the suspected medical device was completed.Investigation summary : during evaluation of the device, it was observed that there were two lines of shell wear in anterior view.There were two (2) tears (a, b) within the two lines of shell wear, located at the anterior view , measuring approximately 0.3 cm (a) and 0.2cm (b).No other anomalies were observed.These kind of findings are consistent with a crease/fold failure which is a known inherent risk associated with the use of saline-filled mammary prostheses and may be the result of one or more of the following contributing factors: underinflation or overinflation of the device, continuous and sustained stresses to the device - such as too small a breast pocket and folding or wrinkling of the shell in the breast pocket, resulting in a tear at a later date.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 10/16/19, the suspected medical device was returned for evaluation.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
• MDR Report Key: 8946805
• Report Number: 1645337-2019-18111
• Device Sequence Number: 16669064
• Product Code: FWM
• UDI-Device Identifier: 00081317001720
• UDI-Public: 00081317001720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2019

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: 11/30/2004
• Device Catalogue Number: 3542615
• Device Lot Number: 219338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/16/2019; 11/15/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/13/2019; 11/18/2019
• 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
• Patient Age: 28 YR