MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	3548215
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Breast Mass (2439); 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, 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.Concomitant products: a mentor cpx 4 breast tissue expander 650cc , catalog number: 3548215, serial number: (b)(4), lot number: 6981549.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast reconstruction primary with a mentor cpx 4 breast tissue expander 650cc and experienced deflation on the left breast implant and breast lump on the left breast implant.The patient had a ct scan done by the healthcare professional that showed fluid leaking from the left tissue expander.As a result, the patient had undergone explantation on (b)(6) 2018.
Additional Manufacturer Narrative
On 12/18/2018, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device contained fluid with white appearance.No foreign material was observed within the device or on the shell surface.The device appeared clean and intact upon visual examination.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.No 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.The complaint of deflation was not confirmed since no anomalies were found on the reported device.At this point it is not possible to determine the origin of the white 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.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.No corrective action is required since there is no evidence that the failures modes are related with manufacturing or product design.(b)(4).
Additional Manufacturer Narrative
On 12/5/2018, it was reported to mentor that the lump the patient felt was related to deflation and not to a breast mass.Breast mass code was removed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that 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).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8056206
• Report Number: 1645337-2018-06745
• Device Sequence Number: 19164278
• Product Code: LCJ
• UDI-Device Identifier: 00081317006565
• UDI-Public: 00081317006565
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2018

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: 10/08/2019
• Device Catalogue Number: 3548215
• Device Lot Number: 6981549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 12/05/2018; 12/18/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 11/12/2018; 12/06/2018; 12/19/2018
• 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
• Patient Age: 41 YR