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	08/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent primary breast reconstruction 550cc mentor cpx 4 breast tissue expander and experienced left sided deflation post procedure.As a result, the device was explanted on (b)(6) 2016.
Additional Manufacturer Narrative
The device history record (dhr) for the lot number 7333104 was reviewed on 5/18/2018 and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned product was completed by the failure analysis lab on 6/22/2018.Device evaluation summary: it was reported that a female patient underwent primary breast reconstruction 550cc mentor cpx 4 breast tissue expander and experienced left sided deflation post procedure.Upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device.Brown material was observed on the shell surface.During examination, the product evaluation team observed a rent on patch.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were found.The complaint was confirmed since a rent was found on the device.The product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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).
Additional Manufacturer Narrative
The device evaluation summary was erroneously submitted without analysis codes on 6/25/2018.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: 7375326
• Report Number: 1645337-2018-01719
• Device Sequence Number: 2311877
• Product Code: LCJ
• UDI-Device Identifier: 00081317006558
• UDI-Public: 00081317006558
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2018

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: 06/04/2020
• Device Catalogue Number: 3548214
• Device Lot Number: 7333104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018; 02/27/2018; 02/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 06/06/2018; 06/25/2018; 06/25/2018
• 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