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

Catalog Number	3504303M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2018
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.The device history record (dhr) was reviewed on (b)(6) 2018, 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).
Event or Problem Description
It was reported that a (b)(6) female patient underwent breast reconstruction revision with a mentor 400cc tissue expander.The device was inflated with 50cc when first implanted and was attempted to inflate more on the second day but the tissue expander experienced a deformation.As a result, the device was replaced with a similar mentor 400cc tissue expander on (b)(6) 2018.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 11/30/2018.The analysis has begun, but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained no fluid.No foreign material was observed within the device or on the shell surface.Mentor product analysis lab discovered a rent at the patch junction.Microscopic examination was performed.No evidence of instrument damage was observed.No other anomalies were discovered.The complaint was confirmed for deformation.At this point it is not possible to determine the root cause of such damage.According to the information received, it was reported by the bq that the product should have a rectangular shape, but it is not in shape.However, no matter how much the surgeon put it, the product expander did not have a rectangular shape.Therefore, they stated having is a problem with the product.Mentor product analysis lab discovered a rent at the patch junction.Microscopic examination was performed.No evidence of instrument damage was observed.No other anomalies were discovered.There is no evidence that the issue is related with manufacturing.Complaint was confirmed for deformation.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.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: 8093050
• Report Number: 1645337-2018-06969
• Device Sequence Number: 13772854
• Product Code: LCJ
• UDI-Device Identifier: 00081317002390
• UDI-Public: 00081317002390
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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: 04/09/2021
• Device Catalogue Number: 3504303M
• Device Lot Number: 7448200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 01/25/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR