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

Catalog Number	3549114
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2018
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 (b)(6) -year-old female patient underwent a breast reconstruction primary with a mentor cpx 4 breast tissue expander with suture tabs 550cc and experienced deflation on the right tissue expander.As a result, the patient had undergone removal and replacement with mentor cpx 4 breast tissue expander with suture tabs 550cc on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the deflation was spontaneous.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 07/06/18, it was reported to mentor that the device history record (dhr) for the lot number 6866853 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 07/17/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the gel contained in the device appears cloudy.No foreign material was observed within the device or on the shell surface.Product evaluation team discovered a rent measuring approximately 0.2 cm at the posterior 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.However, at this point it is not possible to determine the root cause of such damage.There is no evidence that the issue is related with manufacturing.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).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7666330
• Report Number: 1645337-2018-04107
• Device Sequence Number: 11022894
• Product Code: LCJ
• UDI-Device Identifier: 00081317006688
• UDI-Public: 00081317006688
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/14/2018

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: 10/31/2018
• Device Catalogue Number: 3549114
• Device Lot Number: 6866853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/14/2018; 06/14/2018; 06/14/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 07/09/2018; 07/18/2018; 08/06/2018
• 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: 48 YR