MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER 275CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	3548211
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
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.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 a primary breast reconstruction with a mentor cpx 4 breast tissue expander 275cc device that deflated after implantation.As a result, the patient underwent explantation on an unknown date.
Additional Manufacturer Narrative
Upon receipt by mentor, the device returned with clear fluid.No foreign material was observed within the device.Black material was observed on the shell surface.During examination, product evaluation observed a rent measuring approximately <0.1 cm on the anterior aspect.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 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.At this point is not possible to determine the origin of the black material found on the device.There is no evidence that the issue is related with manufacturing.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
On 04/17/2018, 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.On 04/22/2018, mentor received additional information about the event: the date of event was originally reported as (b)(6) 2018.New information states that date of event is (b)(6) 2017.Patient is caucasian.Deflation of suspect medical device was discovered during expander exchange surgery.Patient underwent explantation and replacement with an unspecified expander on (b)(6) 2017.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER 275CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7378547
• Report Number: 1645337-2018-01797
• Device Sequence Number: 16487320
• Product Code: LCJ
• UDI-Device Identifier: 00081317006527
• UDI-Public: 00081317006527
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 06/30/2018
• Device Catalogue Number: 3548211
• Device Lot Number: 6838317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018; 02/27/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/09/2018; 06/30/2018
• 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