MAUDE Adverse Event Report: MENTOR TEXAS SILTEX MEDIUM HEIGHT TISSUE EXPANDER STYLE 7200; EXPANDER, SKIN, INFLATABLE

Catalog Number	3547212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2017
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 device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent reconstruction with mentor tissue expander in (b)(6) on (b)(6) 2015 experienced deflation of device that was observed on (b)(6) 2017.The patient underwent removal and replacement with other mentor tissue expander on(b)(6) 2018.Per mentor ifu, this device should not be implanted anytime exceeding 6 months.Hence, this was an off label use off device as it was implanted for 2 years and 8 months.
Additional Manufacturer Narrative
On 03/20/2018, the device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: SILTEX MEDIUM HEIGHT TISSUE EXPANDER STYLE 7200
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7284647
• Report Number: 1645337-2018-00933
• Device Sequence Number: 164509
• Product Code: LCJ
• UDI-Device Identifier: 00081317003670
• UDI-Public: 00081317003670
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 3547212
• Device Lot Number: 6696524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/17/2018
• 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: Required Intervention
• Patient Age: 61 YR