MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 2 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	3546311
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	12/13/2017
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.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).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast reconstruction procedure with a mentor cpx 2 breast tissue expander 250cc device that deflated after implantation.A hole was identified in the upper pole.In addition, there was serum found plus a yellowish secretion in the pocket.As a result, the patient underwent explantation on (b)(6) 2017.The explanted device was not replaced.
Additional Manufacturer Narrative
On 06/11/2018, mentor completed the analysis on the suspect medical device.Upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.The product evaluation (pe) team discovered two rents.Both rents measured approximately < 0.1 cm and located on the anterior aspect.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.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.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the implant.Infection is a known complication associated with any surgery.Rupture is a known complication associated with these devices and is referenced in our product insert data sheet; however, complaint trends for mentor devices will continue to be monitored by quality assurance.Mentor performs 100% inspection and testing of all devices prior to release.Per a database query, this is the only reported complaint of infection against lot number 6719878.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Pe concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 2 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7515604
• Report Number: 1645337-2018-02921
• Device Sequence Number: 13948192
• Product Code: LCJ
• UDI-Device Identifier: 00081317002307
• UDI-Public: 00081317002307
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 05/31/2017
• Device Catalogue Number: 3546311
• Device Lot Number: 6719878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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
• Patient Age: 52 YR