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

Catalog Number	3548115
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
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.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.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an unknown procedure with a mentor cpx 4 breast tissue expander 650cc prosthesis that could not be inflated intraoperatively.After implantation of expander, the surgeon filled it with saline, however the expander would not inflate.Surgeon used another mentor cpx 4 breast tissue expander 650cc to complete the implantation.There was no patient consequences.There was no adverse event.
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 returned without fluid.No foreign material was observed within the device.Red material was observed on the shell surface.Upon initial inspection the device appears intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.No other anomalies were discovered.The complaint was not confirmed.At this point it is not possible to determine the root cause of the red material found on the device.There is no evidence that the issue is related with manufacturing.Because mentor product analysis lab was unable to confirm any unusual failure mode, no corrective action will be taken at this time.According to the information received, it was reported a deflation and difficulty with expansion fluid removal on a saline breast implant during surgery.Upon initial inspection the device appears intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.No other anomalies were discovered.There is no evidence that the issue is related with manufacturing.Complaint was not confirmed.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; however, deflation trends for mentor saline-filled devices will continue to be monitored by quality assurance.(b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7843367
• Report Number: 1645337-2018-05307
• Device Sequence Number: 19193893
• Product Code: LCJ
• UDI-Device Identifier: 00081317006503
• UDI-Public: 00081317006503
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 3548115
• Device Lot Number: 6937611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 08/05/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 11/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR