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

Model Number	TEXP130RH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: unknown concomitant medical products: unknown.Note: this complaint was created to reflect a device that was received with the complaint reported under manufacturer¿s reference number 1645337-2019-26055.However, it did not match the affected device lot number.Therefore, it will be reported as a blind device.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
On (b)(6) 2019, artoura breast tissue expander 475cc was received by the mentor failure analysis lab with no accompanying information.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, it will be conservatively reported to fda as an event requiring medical device removal from a patient.
Additional Manufacturer Narrative
On 1/21/2020, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 02/21/2020, during visual inspection of the device it was observed with no apparent damage.Leak testing revealed a tear measuring approximately less than 0.1 cm in the anterior view.Microscopic examination was performed and the cause of the rupture could not be identified.Complaint could not be confirmed since there is no event to compare with.At this point, is not possible to determine a root cause of such damage.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if 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: 9592436
• Report Number: 1645337-2020-00893
• Device Sequence Number: 595689
• Product Code: LCJ
• UDI-Device Identifier: 00081317009474
• UDI-Public: 00081317009474
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 12/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: TEXP130RH
• Device Catalogue Number: TEXP130RH
• Device Lot Number: 6980685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 02/21/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/22/2020; 02/21/2020
• 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