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

Catalog Number	3549316
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/27/2017
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 (b)(6) year-old female patient underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander 750cc with suture tabs.Deflation and leaking on the right breast tissue expander were diagnosed post procedure through a physical examination.As a result, the patient underwent unilateral removal and replacement with a mentor cpx 4 breast tissue expander 750cc with suture tabs on (b)(6) 2018.
Additional Manufacturer Narrative
On 6/12/2018.Mentor received additional information: date of event: (b)(6) 2017.Implantation date: (b)(6) 2017.The mentor failure analysis lab received the device for evaluation on 6/12/2018.Device evaluation summary: it was reported that a (b)(6) female patient underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander 750cc with suture tabs.Deflation and leaking on the right breast tissue expander were diagnosed post procedure through a physical examination.As a result, the patient underwent unilateral removal and replacement with a mentor cpx 4 breast tissue expander 750cc with suture tabs on (b)(6) 2018.The device was received at mentor without fluid.Yellow material was observed on the shell surface.During evaluation two rents were observed on the anterior aspect, measuring approximately rent a 0.8 cm and rent b 1 cm.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the product evaluation team was precluded from further evaluating the device.No other anomalies were observed.Complaint was confirmed.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.The device history record (dhr) for the lot number 6889519 was reviewed on 6/7/2018, and it was verified that the device was manufactured in accordance with documented specifications and procedures.At this time is not possible to determine the origin of the yellow material observed.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
On (b)(6) 2019, mentor became aware that previously submitted medwatch report numbers 1645337-2018-03421 and 1645337-2018-03520 were duplicated.Any additional event information, if received, will be submitted under this manufacturer¿s report number.Reason for device explant and/or reoperation: deflation concomitant products: 750cc mentor cpx 4 breast tissue expander with suture tabs(catalog number 3549316, serial number (b)(4).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: 7565785
• Report Number: 1645337-2018-03421
• Device Sequence Number: 13956263
• Product Code: LCJ
• UDI-Device Identifier: 00081317006824
• UDI-Public: 00081317006824
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2018

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: 3549316
• Device Lot Number: 6889519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018; 10/28/2019
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 06/27/2018; 11/12/2019
• 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: 49 YR