MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT; EXPANDER, SKIN, INFLATABLE

Catalog Number	3549336
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation 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 female patient underwent a breast augmentation revision procedure with a mentor cpx4 siltex tall height tissue expander where deflation occurred approximately two weeks after implantation.Additionally, the patient experienced capsular contracture (baker grade i).As a result, the tissue expander was explanted and replaced on (b)(6) 2017.No further information is available.
Additional Manufacturer Narrative
Device evaluation summary: the device was returned to mentor without fluid.Brown material was observed within the device.White material was observed on the shell surface.The product evaluation team (pe) discovered a rent measuring approximately 0.6 cm on the posterior aspect.No other anomalies were discovered.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 or the origin of the white and brown material found on the device.All implants are 100% inspected before leaving the facility.There is no evidence that the issues are related to the manufacturing process.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.(b)(4).
Additional Manufacturer Narrative
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.(b)(4).

• Brand Name: MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7201040
• Report Number: 1645337-2018-00504
• Device Sequence Number: 13746770
• Product Code: LCJ
• UDI-Device Identifier: 00081317009757
• UDI-Public: 00081317009757
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2018

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: 03/07/2020
• Device Catalogue Number: 3549336
• Device Lot Number: 7300201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/02/2018; 01/02/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/19/2018; 05/10/2018
• 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: 48 YR