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	01/01/2018
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.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 breast reconstruction revision with a mentor cpx 4 550cc breast tissue expander.Deflation on the left breast tissue expander was observed post procedure.The physician states there was a hole within the seam of the expander.As a result, the patient underwent removal and replacement with a similar mentor cpx 4 550cc breast tissue expander on (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation summary: the device was received at mentor 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, analysis lab 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.The device history record (dhr) for the lot number 7395601 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Initial allegation indicates the tissue expander had deflated.The device appeared intact.Because the risk of device deflation cannot be eliminated, mentor addresses this risk in the pids by stating that these devices should not be considered lifetime devices.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on (b)(6) 2018.The analysis has begun, but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.The device history record (dhr) was reviewed on (b)(6) 2018, 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).

• 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: 7987461
• Report Number: 1645337-2018-06283
• Device Sequence Number: 13840918
• Product Code: LCJ
• UDI-Device Identifier: 00081317006619
• UDI-Public: 00081317006619
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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: 11/17/2020
• Device Catalogue Number: 3548314
• Device Lot Number: 7395601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 12/18/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/29/2018; 12/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention