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

Catalog Number	3549315
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 female patient underwent breast reconstruction with mentor cpx 4 breast tissue expander with suture tabs 650cc breast prosthesis.Slow leak on one side of the expander while being filled was reported.As a result, the patient was scheduled for removal and second stage implants implantation in (b)(6).
Additional Manufacturer Narrative
On 12/6/2018, mentor became aware that the patient was scheduled for removal on (b)(6) 2018.(b)(4).
Additional Manufacturer Narrative
On (b)(6) 2018, mentor became aware that the suspect medical device's date of implantation was (b)(6) 2018.Mentor also became aware that the suspect medical device has been discarded.In addition, mentor also became aware that the surgeon did not detect any leakage, but felt it was more of a deflation.The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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: 8131603
• Report Number: 1645337-2018-07213
• Device Sequence Number: 252079
• Product Code: LCJ
• UDI-Device Identifier: 00081317006817
• UDI-Public: 00081317006817
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2018

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: 3549315
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 12/19/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/12/2018; 01/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention