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

Catalog Number	3542911
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/22/2018
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent breast augmentation revision with a mentor siltex contour profile moderate 225/250cc saline prosthesis.Deflation on the left breast prosthesis was diagnosed post procedure via self-examination, then confirmed through a physical examination.As a result, the patient is scheduled for breast prosthesis explant on (b)(6) 2018.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed on 5/9/2018, 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).
Additional Manufacturer Narrative
The device history record (dhr) was reviewed on 5/9/2018, 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).
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 7/22/2018.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.Also on 7/22/2018, mentor received additional information: the patient underwent primary breast reconstruction.The patient had the breast prosthesis explanted without replacement on (b)(6) 2018.Complete capsulectomy and flap reconstruction of the breast was indicated.Patient tolerated procedure well and left operating room in stable condition.(b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the device was received at mentor without fluid.No foreign material was observed within the device.Yellow material was observed on the shell surface.The product evaluation team discovered a rent measuring approximately 0.3 cm on the posterior aspect.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.The device history record (dhr) for the lot number 6503086 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.There is no evidence that the issue is related with manufacturing.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7474763
• Report Number: 1645337-2018-02493
• Device Sequence Number: 13496039
• Product Code: FWM
• UDI-Device Identifier: 00081317001850
• UDI-Public: 00081317001850
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/05/2018

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: 08/31/2015
• Device Catalogue Number: 3542911
• Device Lot Number: 6503086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/05/2018; 04/05/2018; 07/22/2018; 08/23/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/17/2018; 05/21/2018; 08/20/2018; 08/23/2018
• 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: 68 YR