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

Catalog Number	3542715
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/21/2018
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.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast reconstruction primary with a saline mentor siltex contour profile high 650cc and experienced deflation on the left breast implant.As a result, the patient had undergone explantation on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device contained no fluid.Red material was observed within the device and yellow material was observed on the shell surface.During evaluation it was observed a rent in length at the shell to patch junction.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were observed.Complaint was confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.A probable cause of the failure could not be determined.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.At this point is not possible to determine the origin of the red and yellow material found in the device.Because mentor product analysis lab was unable to confirm any unusual failure mode, no corrective action will be taken at this time.(b)(4).
Additional Manufacturer Narrative
On 10/30/18, it was reported to mentor that the replacement device was saline mentor siltex contour profile high 550cc breast implant.The implant was completely deflated.The patient was in a good condition after the surgery.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 11/12/18, it was reported to mentor that the mentor failure analysis lab has 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¿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: 7975579
• Report Number: 1645337-2018-06236
• Device Sequence Number: 1681770
• Product Code: FWM
• UDI-Device Identifier: 00081317001942
• UDI-Public: 00081317001942
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2018

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: 02/16/2019
• Device Catalogue Number: 3542715
• Device Lot Number: 6905428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 11/12/2018; 11/21/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/01/2018; 11/12/2018; 11/22/2018
• 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: 49 YR