MAUDE Adverse Event Report: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Model Number	3549315
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	09/07/2021
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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent breast augmentation with a 650cc mentor cpx 4 breast tissue expander with suture tabs experienced deflation post procedure.The device was notably smaller than the contralateral side.There was a visible hole upon explant.The deflation was diagnosed through a physical examination.As a result, an explant was performed on (b)(6) 2021.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on (b)(6) 2021.The analysis has begun but is not complete at this time.When the investigational and analysis have been completed, a supplemental report will be submitted.Additional information was received on (b)(6) 2021.The patient was 48-years-old at the time of the event.The event date was clarified to be (b)(6) 2021.The implant date was clarified to be (b)(6) 2020.The patient was replaced with mentor silicone.The patient is fully recovered.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Manufacturer¿s reference number: (b)(6) on december 1, 2021 mentor became aware that off label use was erroneously omitted from the previous supplemental report.The following statement was added to the device evaluation summary: per mentor instructions for use (ifu), tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off-label manner.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• MDR Report Key: 12551012
• Report Number: 1645337-2021-10886
• Device Sequence Number: 5146162
• Product Code: LCJ
• UDI-Device Identifier: 00081317006817
• UDI-Public: 00081317006817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 06/11/2023
• Device Model Number: 3549315
• Device Catalogue Number: 3549315
• Device Lot Number: 7737707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 11/01/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/27/2021; 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR