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

Catalog Number	3546215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: seroma.(b)(4).This report contains supplemental information for mentor asr/psr reference number (b)(4).This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s asr exemption #e1999017.
Event or Problem Description
It was reported that a (b)(6)-year old female patient who underwent breast reconstruction with a 650cc mentor cpx 2 breast tissue expander on the right side, suffered large amount of seroma post-operatively.As a result, the patient underwent unilateral removal and replacement with a mentor gel implant on (b)(6) 2017.This report contains supplemental information for mentor asr/psr reference number (b)(4).
Additional Manufacturer Narrative
The following information was erroneously omitted in the follow up report number 1 sent on (b)(6) 2019: 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
On (b)(6) 2019, the product investigation was completed.Device investigation summary: during evaluation of the sample it was observed a tear in the anterior view, measurement approximately 7.1 cm.No other anomalies were observed on it.In addition, the manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Excessive postoperative accumulation and/or transient reaccumulation of fluid around an implant most likely occur soon after surgery; however, it can occur at any time.Symptoms from seroma may include swelling, pain, and bruising.While the body absorbs small hematomas and seromas, some will require surgery.Seromas presenting after the immediate post-operative period may require additional work-up by the surgeon.An investigation of the returned device was performed, and mentor could not uncover a device failure that we could connect to the reported medical symptoms.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: 8941359
• Report Number: 1645337-2019-18056
• Device Sequence Number: 2458677
• Product Code: LCJ
• UDI-Device Identifier: 00081317002284
• UDI-Public: 00081317002284
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 3546215
• Device Lot Number: 6798979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/10/2019; 09/10/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/10/2019; 09/10/2019
• 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: 63 YR