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

Catalog Number	3504304M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a mentor tissue expander 700cc was ruptured and leaking.The leaking issue was discovered before the surgery; therefor, there was no patient contact.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
Device evaluation summary: it was reported that a mentor tissue expander 700cc was ruptured and leaking.The leaking issue was discovered before the surgery; therefor, there was no patient contact.The device was returned to mentor with white fluid inside.No foreign material was observed within the device or on the shell surface.Upon initial inspection the device appears intact.Leak testing was performed according with mentor procedures and it revealed four rents measuring approximately < 0.1 cm each one and all located on the anterior aspect.Microscopic examination of the edges of the rents revealed parallel striations.No other anomalies were discovered.The complaint was confirmed since a rupture was found in the device.Microscopic examination revealed parallel striations.This type of striations is more conclusive to sharp instrument damage rather than shell failure due to wear.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).

• 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: 8032844
• Report Number: 1645337-2018-06592
• Device Sequence Number: 13768776
• Product Code: LCJ
• UDI-Device Identifier: 00081317002406
• UDI-Public: 00081317002406
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2022
• Device Catalogue Number: 3504304M
• Device Lot Number: 7566029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 02/18/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/06/2018; 02/25/2019
• Patient Sequence Number: 1