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

Catalog Number	3549216
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2019
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 manufacturing record evaluation history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast reconstruction with a mentor cpx 4 breast tissue expander with suture tabs 800cc and experienced deflation on the left breast implant.As a result, the patient had undergone removal and replacement with mentor cpx 4 breast tissue expander 800cc on (b)(6) 2019.
Additional Manufacturer Narrative
On 4/17/19, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device contained clear fluid.No foreign material was observed within the device or on the shell surface.During initial evaluation the device appeared intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No other anomalies were observed.Deflation 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 could not confirm that an actual failure of the device to conform to expected performance had occurred.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.A manufacturing record evaluation (mre) was performed for the finished device number 7569727, and no non-conformances related to the reported complaint were identified.Because mentor product analysis lab 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 WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8343776
• Report Number: 1645337-2019-08626
• Device Sequence Number: 13979640
• Product Code: LCJ
• UDI-Device Identifier: 00081317006763
• UDI-Public: 00081317006763
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 04/22/2022
• Device Catalogue Number: 3549216
• Device Lot Number: 7569727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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: 58 YR