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

Model Number	3548215
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
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: material rupture.(b)(4).
Event or Problem Description
It was reported that a female patient, who underwent primary breast reconstruction with a 650cc mentor cpx 4 breast tissue expander on an unspecified side, suffered deflation, post-operatively.The deflation was diagnosed during an in office visit.As a result, the patient underwent removal and replacement with a 650cc mentor cpx 4 breast tissue expander (catalog: 3548215 lot: 7568876 sn: (b)(4) on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.Device investigation summary: during visual evaluation no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, and it revealed a tear on the patch on the posterior view, measuring less than 0.1 cm.Please note that due to insufficient paperwork, the analysis from the product evaluation lab was limited to non-destructive testing.Our observations may differ from original findings.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 10764001
• Report Number: 1645337-2020-13902
• Device Sequence Number: 14251873
• Product Code: LCJ
• UDI-Device Identifier: 00081317006565
• UDI-Public: 00081317006565
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 10/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: 3548215
• Device Catalogue Number: 3548215
• Device Lot Number: 7458207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: Required Intervention