MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Catalog Number	3549216
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: 650cc mentor cpx 4 breast tissue expander with suture tabs, catalog #3549216, serial #(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent revision breast reconstruction on (b)(6) 2017 with a 650cc mentor cpx 4 breast tissue expander with suture tabs ((b)(4)) and an 800cc mentor cpx 4 breast tissue expander with suture tabs ((b)(4)).The patient experienced right side expander deflation, left breast capsular contracture (baker grade ii), left side seroma, and a left side tissue expander magnet issue post bilateral mastectomies and reconstruction.The patient underwent bilateral explantation and replacement with mentor implants.Upon explantation, it was noted that the right device was totally deflated and had a hole at the seam of the expander, and was leaking from the reinforced area at the edge of the implant.Excess tissue(skin) both medially and laterally on the right side was excised.The left breast was evacuated of 600 ml of fluid.A total capsulectomy was performed on the left side.The left side tissue expander magnet had reversed polarity as it repelled several different magna finders that were used when device was implanted, and also did this when it was removed from the body.The patient also underwent adjacent tissue transfer to report sunken in deformity at the anterior check wall in the right breast.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 6/7/2018.Device evaluation summary: it was reported that a (b)(6) female patient underwent revision breast reconstruction on (b)(6) 2017 with a 650cc mentor cpx 4 breast tissue expander with suture tabs and an 800cc mentor cpx 4 breast tissue expander with suture tabs.The patient experienced right side expander deflation, left breast capsular contracture (baker grade ii), left side seroma, and a left side tissue expander magnet issue post bilateral mastectomies and reconstruction.This summary relates to the right sided deflated device.Upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.The product evaluation team discovered a rent measuring approximately 0.6 cm on the anterior aspect.No other anomalies were discovered.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the product evaluation team was precluded from further evaluating the device.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.There is no evidence that the issue is related with manufacturing.Because the product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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).
Additional Manufacturer Narrative
The device history record (dhr) of lot number 7331322 was reviewed on 4/10/2018 and no anomalies were found related to this complaint.In addition, the dhr review verifies that the devices were manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7344005
• Report Number: 1645337-2018-01554
• Device Sequence Number: 16492281
• Product Code: LCJ
• UDI-Device Identifier: 00081317006763
• UDI-Public: 00081317006763
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/15/2018

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: 05/26/2020
• Device Catalogue Number: 3549216
• Device Lot Number: 7331322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018; 02/15/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 05/03/2018; 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: 51 YR