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

Catalog Number	3504311M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
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, 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.(b)(4).
Event or Problem Description
It was reported that a female patient underwent an unknown breast augmentation with mentor tissue expender smooth rectangle 700cc saline breast implants which the left side deflated during implantation.As a result, another implant catalog number 3504311m, lot number 7492171 was used on (b)(6) 2018.No patient consequences reported.
Additional Manufacturer Narrative
On 8/24/2018, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained no fluid.Blue material was observed within the device.No foreign material was observed on the shell surface.During visual examination, pe observed the device appears intact.Leak testing was performed in accordance with mentor procedures and revealed one leak on the anterior view caused by a rent that measures less than 0.1 cm.Microscopic examination of the rent edges gave no indication as to its cause.No other anomalies were found.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Product evaluation team concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint of deflation was confirmed since a rent was found on the device.Nonetheless, a microscopic examination of the rent edges was performed, and it did not provide conclusive evidence of what could be the root cause.Furthermore, at this point it is also not possible to determine the origin of the blue material observed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Product evaluation team concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.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: 7709840
• Report Number: 1645337-2018-04381
• Device Sequence Number: 19184740
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/25/2018

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: 08/07/2021
• Device Catalogue Number: 3504311M
• Device Lot Number: 7492171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 09/07/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/27/2018; 09/10/2018
• Patient Sequence Number: 1