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

Model Number	SMXP100RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that an artoura breast tissue expander 225cc being used in a breast reconstruction was found to be deflated during the operation.No adverse event was experienced by the patient.The surgeon used backup devices, and there were no reported patient consequences or procedural delays.
Additional Manufacturer Narrative
On july 14, 2020, mentor became aware that the previously submitted report contained an erroneously marked field: section h1.Type of reportable event should have been marked as "malfunction." relevant fields have been updated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 05, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, mentor completed evaluation of the device.Device evaluation summary: during the visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected in the device.Unfortunately, after a thorough analysis we were unable to confirm your reported event.If you feel this needs to be submitted for additional review, please provide any additional supporting documentation for review.(i.E., post op device photos, videos, and/or pre-operative scans).In addition, all return kits are now assigned and pre-labeled for each unique case.Please confirm the correct device was returned in the pre-labeled return kit.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information is consistently analyzed and monitored by quality assurance to determine when further action is necessary.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: 10266304
• Report Number: 1645337-2020-08563
• Device Sequence Number: 3044653
• Product Code: LCJ
• UDI-Device Identifier: 00081317024286
• UDI-Public: 00081317024286
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2023
• Device Model Number: SMXP100RH
• Device Catalogue Number: SMXP100RH
• Device Lot Number: 7718663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 08/05/2020; 09/01/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/15/2020; 08/17/2020; 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR