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

Catalog Number	3548314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/03/2018
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast surgery procedure with a mentor cpx 4 breast tissue expander 550cc device that deflated after implantation.The patient was undergoing expansion prior to starting radiation therapy.A scan in preparation for the radiation therapy identified fluid buildup around the tissue expander device.The device appeared to be going down, so a leak was suspected.As a result, the patient underwent explantation and replacement with an unspecified device on (b)(6) 2018.
Additional Manufacturer Narrative
On 02/20/2019, mentor completed the investigation on the suspect medical device.Upon receipt by mentor, the gel contained in the device appears clear.No foreign material was observed within the device or on the shell surface.Upon initial inspection, it was discovered a rent measuring 0.2 cm approximately on the anterior aspect.Microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were discovered.The complaint was confirmed since a rupture was found in the device.Microscopic examination revealed parallel striations.This type of striations is more conclusive to sharp instrument damage rather than shell failure due to wear.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.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; however, deflation trends for mentor saline-filled devices will continue to be monitored by quality assurance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2018, the mentor product analysis lab 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: 8191902
• Report Number: 1645337-2018-07520
• Device Sequence Number: 11269241
• Product Code: LCJ
• UDI-Device Identifier: 00081317006619
• UDI-Public: 00081317006619
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup,Followup

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: 03/31/2019
• Device Catalogue Number: 3548314
• Device Lot Number: 6916343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/31/2018; 02/20/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/21/2019; 02/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR