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

Model Number	SMXP140RH
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
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: neoplasm malignant.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with an artoura breast tissue expander 600cc and suffered from a breast invasive ductal carcinoma on the right breast implant.As a result, the patient had undergone removal and replacement with mentor memorygel breast implant 560cc on (b)(6) 2020.
Additional Manufacturer Narrative
On 1/28/2021, mentor became aware that the date problem observed was reported incorrectly.The actual date was (b)(6) 2020.Manufacturer¿s reference number: (b)(4).Corrections: the date problem observed was (b)(6) 2020.
Additional Manufacturer Narrative
After clinical review of this file performed on (b)(6) 2021, it was decided to remove codes medical device removal and neoplasm malignant, and adverse event and add codes no adverse event, no patient consequence, no product quality issue to more accurately capture the reported event.In addition, with the information available at this time, there appears to be no alleged complaint relating to the identity, quality, durability, reliability, usability, safety, effectiveness, or performance of the mentioned devices.This appears to be a staged reconstruction for a breast cancer patient post-mastectomy.Therefore, this event does not meet the criteria for a mdr reportable complaint.Manufacturer¿s reference number: (b)(4).Corrections: removed medical device removal, neoplasm malignant, adverse event codes.

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11233109
• Report Number: 1645337-2021-00713
• Device Sequence Number: 3556135
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: SMXP140RH
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 9383346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021; 01/28/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 01/28/2021; 02/04/2021
• 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: 38 YR