MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 2 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3546112
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/29/2021
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 (b)(6) year-old female patient underwent primary breast reconstruction with a 350cc mentor cpx 2 breast tissue expander that deflated postoperatively.As a result, the patient had the device explanted on (b)(6) 2021.The patient has since recovered fully.The device was implanted on (b)(6) 2016.These devices are indicated for use for a period of six months, and as such, this device was used off-label.
Additional Manufacturer Narrative
On (b)(6) 2021, the device was returned to mentor for analysis.The investigation was completed on (b)(6) 2021.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that the expander had parallel lines of shell wear on the anterior aspect.Leak testing was performed in accordance with mentor procedures, and a tear was observed within the shell wear, measuring approximately 0.1 cm.The evaluation determined that the cause of the rupture was consistent with normal wear.Shell wear suggests in-vivo folding or creasing of the device.This may be the result of continuous and sustained stresses to the device.In mentor's 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.It should be noted that as part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR CPX 2 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11939939
• Report Number: 1645337-2021-06276
• Device Sequence Number: 1297167
• Product Code: LCJ
• UDI-Device Identifier: 00081317002192
• UDI-Public: 00081317002192
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 11/30/2018
• Device Model Number: 3546112
• Device Catalogue Number: 3546112
• Device Lot Number: 6874303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: 59 YR