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

Catalog Number	SMXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/05/2019
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 manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unspecified breast implantation procedure with an artoura breast tissue expander 500cc and experienced deflation (side unknown).As a result, the patient underwent removal on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor received a device with lot number 7739425.This device was confirmed to be the complaint device on (b)(6) 2019.The patient's date of birth was identified as (b)(6)1959, and the patient's age at the time of event has been identified as 60 years old.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: during visual inspection of the device it was observed with no apparent damage.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No anomalies were observed.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.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).

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9396266
• Report Number: 1645337-2019-24792
• Device Sequence Number: 3402946
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2019

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: 06/20/2023
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7739425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 01/03/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/27/2019; 01/03/2020
• 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
• Patient Age: 60 YR