MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS; EXPANDER, SKIN, INFLATABLE

Catalog Number	3547315
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
Medwatch number: mw5088755 it was reported that a female patient underwent an unspecified breast reconstruction with a 650cc mentor cpx 3 breast tissue expander with suturing tabs and experienced postoperative right-sided early onset seroma and left-sided deflation.The seroma needed to be aspirated, and the right-sided tissue expander was removed.The patient reported that the left-sided deflated tissue expander has been implanted for six years, and at the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the left-sided implant.

• Brand Name: MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9111937
• Report Number: 1645337-2019-19748
• Device Sequence Number: 1748737
• Product Code: LCJ
• UDI-Device Identifier: 00081317003779
• UDI-Public: 00081317003779
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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 Catalogue Number: 3547315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/24/2019
• 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: Other