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

Model Number	3548214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Cancer (3262)
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 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: breast cancer.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a revision breast reconstruction with a 550cc mentor cpx 4 breast tissue expander and experienced postoperative right-sided breast cancer.As a result, the patient¿s expander was replaced with a 500cc mentor smooth round moderate plus profile prosthesis (catalog #: 3502500, lot #: 9371038) on (b)(6) 2019.Multiple attempts were made to obtain additional details regarding this event.However, no further information has been received at this time.A supplemental report will be submitted if additional information becomes available in the future.
Additional Manufacturer Narrative
On (b)(6) 2020, after additional review of the complaint information, mentor concluded that there is no apparent adverse event or malfunction reported regarding the event.The patient was a cancer patient.With the available information, the exchange appears to be part of a staged reconstruction only.If additional information is received in the future, a supplemental report will be submitted.The date of implantation was updated from (b)(6) 2018 to (b)(6) 2019.Since only the lot number was provided for the device, the date was estimated based on the earliest invoice date from the lot number.The relevant filed has been updated.The investigation on the suspected medical device was completed.Investigation summary: the device was visually inspected, and no apparent damage was found.An investigation of the returned device was performed, and mentor could not uncover a device failure that we could connect to the reported medical symptoms.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: 9833022
• Report Number: 1645337-2020-04208
• Device Sequence Number: 19018423
• Product Code: LCJ
• UDI-Device Identifier: 00081317006558
• UDI-Public: 00081317006558
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: 3548214
• Device Catalogue Number: 3548214
• Device Lot Number: 7724532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: Life Threatening; Required Intervention