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

Model Number	3548215
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/24/2020
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent breast reconstruction with 650cc mentor cpx 4 breast tissue expanders and experienced deflation on the right side postoperatively.As a result, the patient underwent device removal and replacement with a similar product on (b)(6) 2020.
Additional Manufacturer Narrative
Additional information: on november 17, 2020, the mentor failure analysis lab 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.Mentor also became aware of the lot number and the correct catalog number of the impacted product.The relevant fields in this report have been updated to reflect the impacted device attributes (catalog number, lot number, udi number, manufacturing date, expiration date and device returned to manufacturer date).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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On december 23, 2020, the product investigation was completed.Device investigation summary: during visual evaluation a tear was observed on the union between shell and patch on posterior view.Microscopic examination was performed and the cause of the tear could not be identified.Causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 10840896
• Report Number: 1645337-2020-14586
• Device Sequence Number: 16869775
• Product Code: LCJ
• UDI-Device Identifier: 00081317006565
• UDI-Public: 00081317006565
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2020

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: 04/04/2021
• Device Model Number: 3548215
• Device Catalogue Number: 3549215
• Device Lot Number: 7448550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/17/2020; 12/23/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/05/2020; 12/28/2020
• 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