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

Catalog Number	3505305M
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor asr 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.Device evaluation summary: the device was received with a trace of clear fluid.No foreign material was observed within the device and on the shell surface.Device appears clean and intact.Leak testing revealed a rent that measured approximately < 0.1cm on the anterior aspect and no difficulty with expansion.No anomalies were discovered.A manufacturing record evaluation (mre) was performed for the finished device number 7317205, and no non-conformances related to the reported complaint condition were identified.Because mentor performs 100% inspection and testing of all devices prior to release, the mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.Because the risk of device deflation cannot be eliminated, mentor addresses this risk in the pids by stating that these devices should not be considered lifetime devices.(b)(4).
Event or Problem Description
This report contains supplemental information for mentor asr reference number (b)(4).It was reported that a patient underwent an unspecified surgery with a mentor tissue expander 250cc device that was difficult to expand.In addition, there was a spill of physiological solution.This issue was reported for the left breast device.As a result, the patient underwent explantation on (b)(6) 2017.

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8940435
• Report Number: 1645337-2019-18030
• Device Sequence Number: 2609654
• Product Code: LCJ
• UDI-Device Identifier: 00081317002581
• UDI-Public: 00081317002581
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2020
• Device Catalogue Number: 3505305M
• Device Lot Number: 7317205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/28/2019
• 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