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

Model Number	TEXP120RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/11/2021
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent primary breast augmentation with a 535cc artoura breast tissue expander and experienced right side expander deflation postoperatively.As a result, the expander was explanted and replaced with catalog number texp120ruh; serial number (b)(4) on (b)(6) 2021.The impacted serial number is either (b)(4).Supplemental report will be submitted when information is received.
Additional Manufacturer Narrative
On june 14, 2021, mentor became aware that the impacted serial number was (b)(6).Field d4 has been updated on this form.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 25, 2021, 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) 2021, device evaluation was completed.Device evaluation summary: investigation was performed to see if root cause of deflation could be determined.The investigation included a review of the manufacturing records for lot-7632601, 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, the shell of the tissue expander was observed blue.When evaluated under a microscope the tear 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.In addition, as stated in the product insert data sheet, is contraindicated to place drugs or substances inside the tissue expanders other than sterile saline for injection since this could compromise the product integrity.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).

• 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: 11952480
• Report Number: 1645337-2021-06376
• Device Sequence Number: 1059170
• Product Code: LCJ
• UDI-Device Identifier: 00081317009542
• UDI-Public: 00081317009542
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/11/2021

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: 09/21/2022
• Device Model Number: TEXP120RUH
• Device Catalogue Number: TEXP120RUH
• Device Lot Number: 7632601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/14/2021; 06/25/2021; 07/07/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/15/2021; 07/06/2021; 07/07/2021
• 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: 43 YR