MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS; EXPANDER, SKIN, INFLATABLE

Model Number	3547315
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	12/31/2013
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: generalized illness, capsular contracture baker grade unknown and deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent primary breast reconstruction surgery with 650cc mentor cpx 3 breast tissue expander with suturing tabs experienced bilateral swelling, chronic pain, fatigue, lack of sleep, insomnia, edema, avid lymph nodes, left sided breast pain and left sided deflation post procedure.Patient also had tissue expanders in for more than 6 years.As a result, patient had an explantation on (b)(6) 2019.This report is for the left sided device.See 1645337-2020-00200 for contralateral prosthesis report.
Additional Manufacturer Narrative
Additional information was received on 1/21/2020, hcp confirmed patient did not experience left sided deflation post procedure.Reason for device explant and/or reoperation: generalized illness and capsular contracture baker grade unknown 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2020.Patient reported left sided deflation to fda via mw5092507 on (b)(6) 2020 with an explantation on the left side on 2/1/2014.However, per physician, the device was reported not deflated.Therefore, deflation will not be coded.If more information is received, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9547503
• Report Number: 1645337-2020-00204
• Device Sequence Number: 16737998
• Product Code: LCJ
• UDI-Device Identifier: 00081317003779
• UDI-Public: 00081317003779
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 3547315
• Device Catalogue Number: 3547315
• Device Lot Number: 6661071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 02/19/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/31/2020; 03/11/2020
• 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
• Patient Age: 49 YR