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

Catalog Number	3549111
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/19/2018
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.Manufacturer¿s reference number: (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 250cc breast prosthesis.The patient reported that the left breast prosthesis had deflated.As a result, the patient underwent removal and replacement with an unknown breast prosthesis on (b)(6) 2018.
Additional Manufacturer Narrative
On 5/4/2018, mentor became aware that the correct suspect medical device date of implantation was (b)(6) 2017.On 5/7/2018, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2018, upon receipt by mentor, the device contained fluid with clear appearance.No foreign material was observed within the device or on the shell surface.During visual examination of the device, product evaluation observed a rent at the shell to patch junction.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, product evaluation was precluded from further evaluating the device.No anomalies were found.Because mentor performs 100% inspection and testing of all devices prior to release, product evaluation concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint of deflation was confirmed since a rent was found on the reported device.However, at this point it is not possible to determine the root cause of such damage.Mentor performs 100% inspection and testing of all devices prior to release; product evaluation concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.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).

• 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: 7485210
• Report Number: 1645337-2018-02643
• Device Sequence Number: 1456688
• Product Code: LCJ
• UDI-Device Identifier: 00081317006657
• UDI-Public: 00081317006657
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2018

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: 12/31/2018
• Device Catalogue Number: 3549111
• Device Lot Number: 6884038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/05/2018; 04/05/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/29/2018; 06/28/2018
• 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