MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	3548213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069); No Code Available (3191)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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.In addition, the sterilization records were reviewed and no issue was found.No additional complaints were reported under the same lot number.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient who underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander 450cc device and acellular dermal matrix on (b)(6) 2019 developed left side seroma and infection with staphylococcus aureus bacteria that was observed on (b)(6) 2019.The patient underwent explantation on (b)(6) 2019.Per reporter, the patient had the expander replaced (date of implantation unknown).The patient was hospitalized until (b)(6) 2019 and was reported to be in stable condition post explantation.The device was discarded and therefore device analysis cannot be completed.There was no issue reported with look or feel of the device preoperatively and no known problem reported with the packaging.Furthermore, the surgeon placed the implant into the patient.This issue is most likely related to patient's pre-existing condition.Furthermore, an adermal cellular matrix was placed with the implant, which also has the potential to cause patient inflammatory reaction.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8406101
• Report Number: 1645337-2019-09103
• Device Sequence Number: 2326141
• Product Code: LCJ
• UDI-Device Identifier: 00081317006541
• UDI-Public: 00081317006541
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 08/08/2022
• Device Catalogue Number: 3548213
• Device Lot Number: 7611933
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR