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

Model Number	SMXP150RH
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2020
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.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: right deflation and broken suture tab.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient of an unknown age, race, and ethnicity underwent a unspecified breast reconstruction with 750cc artoura breast tissue expander and experienced a deflation and a broken suture tab on her right side post-operatively.As a result, the patient underwent explantation, and replacement with catalog number smxp150rh; serial number (b)(4) on (b)(6) 2020.
Additional Manufacturer Narrative
On august 5, 2020, mentor became aware that report source under field g3 was incorrectly chosen as "company rep" under initial submission.It has been corrected on this form to "health professional".Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 17, 2020, device evaluation was completed.Device evaluation summary: upon a visual evaluation of the device, a tear was observed at the union between shell and suture tab at 6 o¿clock position.Additionally, a tear was noted at the union between shell and patch in the anterior view.Microscopic examination was performed in both tears, and the cause of the rupture could not be identified.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).
Additional Manufacturer Narrative
On september 21, 2020, device re-evaluation was completed, and additional verbiage was added to the investigation summary.Upon receipt of the device, an investigation began to see if the determine the root cause of the deflation can be determined.That investigation included a review of the manufacturing records for lot-9372602, and a visual evaluation of the device.No leak test was necessary to determine the location of the tear as we observed a tear at the union between the shell and the suture tab in the 6 o¿clock position.Additionally, a tear was noted at the union between shell and patch in the anterior view.When evaluated under a microscope the both tears pattern did not reveal parallel striations that are consistent with markings made by a sharp instrument.The results also confirmed that there were no abnormalities with the manufacturing of the tissue expander that would have impacted its performance.Therefore, we were unable to identify the root cause of this tear.Potential cause: while deflation is historically the most common complication related to tissue expanders, the rate of deflation with mentor® tissue expanders remains very low.An incident of this nature may be the result of one or more of the following factors: over inflation of the tissue expander, use of the tissue expander in emerging surgical techniques not identified in the instructions for use (ifu), continuous and sustained stresses to the tissue expander, vigorous body movement (e.G.Physical exercise) or excessive manipulation/ trauma in the region of the expander.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 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.On (b)(6) 2020, mentor became aware that lot number field d4 was mistakenly left blank under the initial submission.It has been correctly updated to "9372602" on this form.On (b)(6) 2020, mentor also became aware that incorrect lot manufacturing and expiration dates were inadvertently reported under initial submission.The dates have been corrected on this form under fields h4 and d4 respectively on this form.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: 10359073
• Report Number: 1645337-2020-09535
• Device Sequence Number: 11362422
• Product Code: LCJ
• UDI-Device Identifier: 00081317024347
• UDI-Public: 00081317024347
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/21/2020

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: 10/02/2023
• Device Model Number: SMXP150RH
• Device Catalogue Number: SMXP150RH
• Device Lot Number: 9372602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/05/2020; 09/03/2020; 09/17/2020; 09/21/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/05/2020; 09/08/2020; 09/17/2020; 09/21/2020
• 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: 42 YR