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

Catalog Number	3548212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
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.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 a patient underwent an unknown procedure with mentor cpx 4 breast tissue expander 350cc saline breast implants that intraoperatively when surgeon tried to fill with saline it leaked.He removed the tissue expander and tested it outside the patient and confirmed it was leaking.They opened another tissue expander and inserted it and filled it with saline and everything went well.No patient consequences reported.
Additional Manufacturer Narrative
On (b)(6) 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.(b)(4).
Additional Manufacturer Narrative
On 8/23/2018, 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).
Additional Manufacturer Narrative
Additional information received on 8/27/2018, indicated that the date of implantation and explant was on (b)(6) 2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device was received with white fluid.The device appeared intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, pe was precluded from further evaluating the device.No anomalies were observed.Complaint was not confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.A root cause failure analysis will not be conducted since the investigation of the reported failure could not confirm that an actual failure of the device to conform to expected performance had occurred.All the implants are 100% inspected before leaving the facility.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: 7811068
• Report Number: 1645337-2018-05146
• Device Sequence Number: 19210084
• Product Code: LCJ
• UDI-Device Identifier: 00081317006534
• UDI-Public: 00081317006534
• 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,Followup,Followup
• Report Date (Section B): 07/30/2018

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: 04/20/2022
• Device Catalogue Number: 3548212
• Device Lot Number: 7566511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 07/30/2018; 09/13/2018; 10/09/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 08/24/2018; 08/28/2018; 09/17/2018; 10/09/2018
• Patient Sequence Number: 1