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

Catalog Number	3542712
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2019
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.Manufacturerâ¿¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with an 350cc mentor siltex contour profile spectrum saline breast implant and experienced postoperative bilateral deflation.The diagnosis was confirmed by a physician upon examination.As a result, the patient underwent bilateral explantation on (b)(6) 2019 and replaced with unspecified breast implants.This report is for the patient's left-sided device.
Additional Manufacturer Narrative
On 12/23/2019, mentor 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.Manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
Mentor received an update on the events submitted in the initial report.The patient underwent bilateral explantation on (b)(6) 2019 as opposed to (b)(6) 2019.This supplemental report has been updated accordingly.Manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
On 1/6/2020, the product investigation was completed.Device investigation summary: during visual evaluation of the sample, a leakage was noted in the anterior view, measuring approximately 0.3 cm.Microscopic examination was performed, and no evidence of instrument damage was observed.No other anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Mentor became aware of event details that were submitted in error in the previous supplemental report.Correction: the patient implanted a 350cc mentor siltex contour profile high.The section d device information has been updated accordingly on this supplemental report.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.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: 9377815
• Report Number: 1645337-2019-24582
• Device Sequence Number: 3039693
• Product Code: FWM
• UDI-Device Identifier: 00081317002147
• UDI-Public: 00081317002147
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/07/2019

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: 08/02/2009
• Device Catalogue Number: 3542712
• Device Lot Number: 5622794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 12/23/2019; 01/06/2020; 01/06/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/23/2019; 12/24/2019; 01/06/2020; 01/06/2020
• 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: 61 YR