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

Catalog Number	3548211
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2018
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.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old female patient underwent a breast reconstruction primary procedure with a mentor cpx 4 breast tissue expander 275cc and experienced deflation on the left tissue expander.The deflation was observed as the tissue expander was leaking.As a result, the patient had undergone explantation on (b)(6) 2018.
Additional Manufacturer Narrative
On 06/30/18, 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).
Additional Manufacturer Narrative
On 08/13/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device was received with clear fluid.Green material was observed on shell surface.During evaluation, a rent on shell patch junction was observed.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, product evaluation team was precluded from further evaluating the device.No other anomalies were observed.Complaint was confirmed.Mentor performs 100% inspection and testing of all devices prior to release.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.All the implants are 100% inspected before leaving the facility.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.At this time is not possible to determine the origin of the green material observed.Because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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: 7498995
• Report Number: 1645337-2018-02747
• Device Sequence Number: 333683
• Product Code: LCJ
• UDI-Device Identifier: 00081317006527
• UDI-Public: 00081317006527
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2018

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 Catalogue Number: 3548211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 04/18/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 07/02/2018; 08/13/2018
• 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: 55 YR