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

Catalog Number	3548213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: according to the reported information, the patient experienced a deflation in the tissue expander implant.Upon visual inspection of the pictures, it was observed that the tissue expander was ruptured.No other anomalies were observed.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.All mentor product is 100% inspected prior to release, in addition to thorough in-process testing during several stages of the manufacturing process.Reason for device explant and/or reoperation: left-sided rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) patient underwent a breast reconstruction with a 450cc mentor cpx 4 breast tissue expander and experienced postoperative left-sided rupture.As a result, the patient underwent removal and replacement with 450cc mentor cpx 4 breast tissue expander (catalog #: 3548213, serial # : (b)(4)) on (b)(6) 2019.
Additional Manufacturer Narrative
On 12/27/19, the investigation on the suspected medical device was completed.Investigation summary: during visual evaluation of the device, a tear was observed in anterior view measuring approximately less than 0.1 cm.Microscopic examination was performed.No evidence of instrument damage was observed.No other anomalies were discovered.Possible causes of deflation of tissue expander implants include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 11/01/19, the suspected medical device was returned 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.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: 9263961
• Report Number: 1645337-2019-22788
• Device Sequence Number: 11232659
• Product Code: LCJ
• UDI-Device Identifier: 00081317006541
• UDI-Public: 00081317006541
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 10/03/2019

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: 10/24/2022
• Device Catalogue Number: 3548213
• Device Lot Number: 7644450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 11/01/2019; 12/27/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/27/2019; 12/31/2019
• 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: 42 YR