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

Model Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2019
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 manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 550cc mentor tissue expander being used for a skin reconstruction ruptured intraoperatively.During a tissue expander replacement surgery, the surgeon found that the device was not inflating due to sudden shear.As a result, the device was replaced intraoperatively with a 550cc mentor tissue expander (catalog #: 3504310m, serial #: (b)(4)).No patient consequences or procedural delays were reported.At the time of this report, there is no evidence of a need for additional surgical intervention, but a supplemental report will be sent if additional information is received.
Additional Manufacturer Narrative
On 2-mar-2020, the investigation on the suspected medical device was completed.Investigation summary : during the visual inspection of the device, a tear was noted in the anterior view, measuring approximately 1.5 cm.Microscopic examination was performed and the cause of the rupture could not be identified.Possible causes of deflation of saline-filled expanders include, but are not limited to, the following events: mechanical damage prior to or during surgery, damage from surgical instruments, use of too small an incision for introduction of the device, damage to the expander during the injection/filling stage.Excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 9548458
• Report Number: 1645337-2020-00115
• Device Sequence Number: 19448177
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 12/05/2019

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: 03/01/2022
• Device Model Number: 3504310M
• Device Catalogue Number: 3504310M
• Device Lot Number: 7548334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1