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

Catalog Number	3504303M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2018
Type of Reportable Event	Serious Injury
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 patient had undergone a breast reconstruction revision procedure with a mentor tissue expander 400cc and expander exploded on the left breast implant while placing into pouch which was prepared previously.It is unknown if there was patient contact with the device.As a result, the patient had a replacement with a mentor tissue expander 400cc on (b)(6) 2018.
Additional Manufacturer Narrative
On 06/07/18, it was reported to mentor that the device history record (dhr) for the lot number 7365419 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 06/11/18, it was reported to mentor that health care facility is (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 06/20/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device.Red material was observed on the shell surface.Product evaluation team discovered a rent measuring approximately 1 cm on the anterior aspect.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.At this point is not possible to determine the red material found on the device.Because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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).
Additional Manufacturer Narrative
On 05/17/18, it was reported incorrectly that the patient¿s age and date of birth were unknown.In addition, it was reported incorrectly that it was unknown that if there was a patient contact with the device.The saline or silicone did not leak into the patient.The patient¿s date of birth was (b)(6).The actual month and day of birth are unknown.The patient¿s age was (b)(6) at the time of the event.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: 7524517
• Report Number: 1645337-2018-02995
• Device Sequence Number: 19256527
• Product Code: LCJ
• UDI-Device Identifier: 00081317002390
• UDI-Public: 00081317002390
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/28/2018

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: 08/22/2020
• Device Catalogue Number: 3504303M
• Device Lot Number: 7365419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 04/28/2018
• Supplement Date Received by Manufacturer: 04/28/2018; 04/28/2018; 04/28/2018; 04/28/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/07/2018; 06/11/2018; 06/21/2018; 06/21/2018
• 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