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

Catalog Number	3548213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 9/11/2018.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 8/29/2018, 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) caucasian patient underwent primary breast reconstruction with a mentor cpx 4 breast 450cc tissue expander.Deflation on the right breast tissue expander was diagnosed post procedure via self-examination at home.As a result, the breast tissue expander was removed and replaced from the patient on (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation summary: the device was received at mentor containing yellow fluid.During evaluation the device appeared intact.Leak testing of the device, in accordance with mentor procedures, revealed a rent on the junction of patch to shell.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were observed.Complaint was confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.The device history record (dhr) for the lot number 7522953 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.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: 7882950
• Report Number: 1645337-2018-05612
• Device Sequence Number: 11389775
• Product Code: LCJ
• UDI-Device Identifier: 00081317006541
• UDI-Public: 00081317006541
• 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): 08/27/2018

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: 11/05/2021
• Device Catalogue Number: 3548213
• Device Lot Number: 7522953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/16/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR