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

Model Number	SMXP140RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
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 (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.Reason for device explant and/or reoperation: deflation.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a revision breast reconstruction with a 600cc artoura breast tissue expander prosthesis and experienced postoperative left-sided deflation.The diagnosis was confirmed by a healthcare professional.At the time of event, the patient¿s surgeon completed two fills into the expander, and the patient was less than two months in for the expansion process.As a result, the patient underwent explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On 11-nov-2020, the investigation on the suspected medical device was completed.Investigation summary : during visual evaluation of the device, no apparent damage or visual anomalies were observed.Leak testing was performed on the device, and the result revealed a tear at the juncture of the shell and front patch.Microscopic examination was performed on the device, and the cause of the rupture could not be identified.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 16-nov-2020, mentor received additional information regarding the revision surgery and replacement device.The patient underwent removal and replacement with a 600cc rtoura breast tissue expander (catalog #: smxp140rh, serial #: (b)(4)).Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, it was found that pma/510k was omitted on the initial report.The pma/510k for the reported device is k161176.The relevant field has been updated.It was found that the product return was omitted on the previous report.The suspected medical device was returned on (b)(6) 2020.The relevant fields have been updated.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.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: 10659965
• Report Number: 1645337-2020-12880
• Device Sequence Number: 11549822
• Product Code: LCJ
• UDI-Device Identifier: 00081317024330
• UDI-Public: 00081317024330
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2020

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: 12/10/2023
• Device Model Number: SMXP140RH
• Device Catalogue Number: SMXP140RH
• Device Lot Number: 9401236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/10/2020; 11/11/2020; 11/16/2020
• Initial Report FDA Received Date: 10/10/2020
• Supplement Report FDA Received Date: 10/28/2020; 11/12/2020; 11/19/2020
• 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: 56 YR