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

Catalog Number	3549211
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that during pre-operation with a mentor cpx 4 breast tissue expander with suture tabs 275cc, the doctor noticed that the implant expander had a hole and was leaking.The event was on (b)(6) 2018.
Additional Manufacturer Narrative
Upon receipt by mentor, the device contained fluid with clear appearance.No foreign material was observed within the device.Gel was observed on the shell surface.During visual examination, product evaluation observed the device appears intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, product evaluation was precluded from further evaluating the device.No anomalies were found.The complaint of deflation was not confirmed since no anomalies were found on the reported device.At this point, it is not possible to determine the root cause of the material observed on the shell surface.Mentor performs 100% inspection and testing of all devices prior to release.The device history record (dhr) of lot number 6843607 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.Because the risk of device deflation cannot be eliminated, mentor addresses this risk in the pids by stating that these devices should not be considered lifetime devices.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: 7444635
• Report Number: 1645337-2018-02343
• Device Sequence Number: 19320094
• Product Code: LCJ
• UDI-Device Identifier: 00081317006718
• UDI-Public: 00081317006718
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 07/31/2018
• Device Catalogue Number: 3549211
• Device Lot Number: 6843607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1