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

Model Number	3548216
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2015
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 manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: migration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a breast reconstruction primary with mentor cpx 4 breast tissue expanders 800cc and experienced bilateral device migration post-operatively.As a result, the patient underwent removal and replacement with mentor saline breast implants (serial numbers (b)(4)) on (b)(6) 2016.This report is for the right breast prosthesis.Per the ifu, this device was used in an off-label manner.This device is not intended for use beyond six months.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDERS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11777730
• Report Number: 1645337-2021-04972
• Device Sequence Number: 3946315
• Product Code: LCJ
• UDI-Device Identifier: 00081317006572
• UDI-Public: 00081317006572
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 01/31/2019
• Device Model Number: 3548216
• Device Catalogue Number: 3548216
• Device Lot Number: 6891388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/05/2021
• 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
• Patient Age: 54 YR