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

Catalog Number	3548214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 7/15/2018.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.The device history record (dhr) was reviewed on 7/12/2018, 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander 550cc noticed the tissue expander to be deflated one morning after implantation.As a result, the patient underwent unilateral removal and replacement with an unspecified air expander on (b)(6) 2018.
Additional Manufacturer Narrative
The following changes were mistakenly omitted from the report submitted on 7/16/2018: is product problem: check.Is adverse event: check.Is required intervention: check.Device evaluation summary: the device was received at mentor containing clear fluid.The product evaluation team observed a rent in length at the shell to patch junction.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.No other anomalies were observed.Complaint was confirmed.Because mentor performs 100% inspection and testing of all devices prior to release, the product evaluation team concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.A probable cause of the failure could not be determined.The device history record (dhr) for the lot number 7521769 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.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 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: 7691238
• Report Number: 1645337-2018-04289
• Device Sequence Number: 14146023
• Product Code: LCJ
• UDI-Device Identifier: 00081317006558
• UDI-Public: 00081317006558
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2018

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: 10/31/2017
• Device Catalogue Number: 3548214
• Device Lot Number: 7521769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2018
• Initial Date Received by Manufacturer: 06/24/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: 46 YR