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

Catalog Number	3548213
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2019
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: inflation problem.Concomitant medical products: a mentor cpx 4 breast tissue expander 450cc., catalog number 3548212, serial number (b)(4), lot number 7680439.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation primary with a mentor cpx 4 breast tissue expander 450cc.The tissue expander was put in the patient and when the surgeon went to fill the expander it would not fill properly.The surgery was delayed by five minutes but there was no report of this causing any issue for the patient.The replacement device was implanted without issue on (b)(6) 2019.
Additional Manufacturer Narrative
On 7/12/2019, according to the information provided, it was reported that the tissue expander was put in the patient and when the doctor went to fill the expander it would not fill properly so he removed it in case it was defective during evaluation of the sample it appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected and the fluid was removed without difficulty.No anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Tissue expander breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.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: 8692357
• Report Number: 1645337-2019-13727
• Device Sequence Number: 2017463
• Product Code: LCJ
• UDI-Device Identifier: 00081317006541
• UDI-Public: 00081317006541
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 04/12/2023
• Device Catalogue Number: 3548213
• Device Lot Number: 7710824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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: 46 YR