MAUDE Adverse Event Report: MENTOR TEXAS SILTEX LOW HEIGHT TISSUE EXPANDER STYLE 9100, 350CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	3549112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other companies¿ device were used in this study: (b)(6).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.(b)(4).
Event or Problem Description
This complaint is from a literature source.Initially current event was covered in mwr-02032018-0000066025.Additional information was received from author on 03/02/2018.Details of 7 patients were provided, therefore current report is to report complication of patient #3, other 6 patients are submitted to fda separately.It was reported that patient #3 in the post intervention group underwent breast reconstruction surgery and suffered infection resulting in explantation.Infections occurred within the first 6 weeks following surgery.Mentor device with catalog 354-9112, lot 6768598 was used.Date of infection was (b)(6) 2013.Infection was procedure related, no body impairment was involved.Patient required hospitalization, surgery, antibiotics and fully recovered.Title: ¿absorbable antibiotic beads prophylaxis in immediate breast reconstruction.¿ the purpose of this study was to evaluate the effects of this protocol modification on periprosthetic infection rates that resulted in explantation of the expander.The study was conducted from dec 2012 to june 2016.
Additional Manufacturer Narrative
The device history record (dhr) for the lot number 6768598 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

• Brand Name: SILTEX LOW HEIGHT TISSUE EXPANDER STYLE 9100, 350CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7385579
• Report Number: 1645337-2018-01257
• Device Sequence Number: 16417141
• Product Code: LCJ
• UDI-Device Identifier: 00081317006664
• UDI-Public: 00081317006664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 10/31/2017
• Device Catalogue Number: 3549112
• Device Lot Number: 6768598
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/15/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR