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	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak test, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage was observed on the tissue expander.Leak testing was performed in accordance with mentor procedures over the device and it was identified ruptured between the joint of the shell and the patch in the posterior view.Microscopic examination was performed and the cause of the deflation could not be identified.In mentor instructions for use (ifu), it is mentioned that tissue expanders are not intended for implantation beyond six months.Therefore, this device was used in an off-label manner.A manufacturing record evaluation was performed for the finished device lot number 7579214 and no non-conformances were identified.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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 underwent an unspecified breast implantation procedure with a mentor cpx 4 breast tissue expander with suture tabs 650cc and experienced deflation on the right side post-operatively, which was confirmed during a physical exam.As a result, the patient underwent removal and replacement with a mentor tissue expander (serial number (b)(4)) on (b)(6) 2021.In mentor instructions for use (ifu), it is mentioned that tissue expanders are not intended for implantation beyond six 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: 12753930
• Report Number: 1645337-2021-12305
• Device Sequence Number: 13816483
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 04/26/2022
• Device Model Number: 3549315
• Device Catalogue Number: 3549315
• Device Lot Number: 7579214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2018
• 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: 68 YR