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

Catalog Number	3542714
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation on (b)(6) 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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent primary breast reconstruction with a mentor siltex contour profile high 550cc saline prosthesis.Deflation on the right breast prosthesis was diagnosed post procedure via self-examination.As a result the patient underwent unilateral removal and replacement with a mentor memoryshape breast implant 570cc gel prosthesis on (b)(6) 2018.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed on (b)(6) 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.(b)(4).
Additional Manufacturer Narrative
Device evaluation summary: it was reported that a (b)(6) female patient underwent primary breast reconstruction with a mentor siltex contour profile high 550cc saline prosthesis.Deflation on the right breast prosthesis was diagnosed post procedure via self-examination.As a result the patient underwent unilateral removal and replacement with a mentor memoryshape breast implant 570cc gel prosthesis on (b)(6) 2018.The device was received at mentor without fluid.Brown material was observed within the device and white on the shell surface.During evaluation two rents were observed on the posterior aspect, measuring approximately rent a 0.5 cm and rent b 0.4 cm.Parallel lines of shell wear were also observed on the anterior aspect, suggesting in-vivo folding or creasing of the device.Leak testing of the device, in accordance with mentor procedures, revealed no other leakage sites.Microscopic examination of the edges of the rents gave no indications as to cause.Complaint was confirmed.Mentor performs 100% inspection and testing of all devices prior to release, the product evaluation team performed concluded that the rent and crease occurred sometime subsequent to the removal of the device from its protective packaging.At this time is not possible to determine the origin of the brown and white material observed.The device history record (dhr) of lot number 5926760 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.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.All the implants are 100% inspected before leaving the facility.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 HIGH
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7355660
• Report Number: 1645337-2018-01580
• Device Sequence Number: 11197664
• Product Code: FWM
• UDI-Device Identifier: 00081317001935
• UDI-Public: 00081317001935
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2018

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: 08/31/2013
• Device Catalogue Number: 3542714
• Device Lot Number: 5926760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 02/21/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/17/2018; 06/27/2018
• 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: 70 YR