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)
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.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.(b)(4).
Event or Problem Description
It was reported that a female patient underwent breast reconstruction with mentor cpx 4 breast tissue expander 8200, 550cc style that failed to retain fluid after implantation.The tissue expander was inside the patient for longer than six months due to the patient requiring extended chemotherapy and radiation treatment.As a result, the patient scheduled to replace it with breast implant on (b)(6) 2018.
Additional Manufacturer Narrative
On 6/26/2018, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device was received with turbid fluid.Black material was observed within the device.The device appeared intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, product evaluation team was precluded from further evaluating the device.No anomalies were observed.Complaint was not confirmed.Mentor performs 100% inspection and testing of all devices prior to release.A root cause of the failure could not be determined.All the implants are 100% inspected before leaving the facility.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).

• 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: 7319618
• Report Number: 1645337-2018-01288
• Device Sequence Number: 18859417
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018; 02/06/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 06/29/2018; 08/09/2018
• 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