MAUDE Adverse Event Report: MENTOR TEXAS MEDIUM HEIGHT TE 550CC; EXPANDER, SKIN, INFLATABLE

Model Number	3548214
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2021
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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent unspecified breast reconstruction with a mentor cpx 4 breast tissue expander, 550cc, saline prosthesis experienced left sided deflation post procedure.As a result patient had the expander removed with no replacement on (b)(6) 2021.
Additional Manufacturer Narrative
On february 4, 2021, 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).
Additional Manufacturer Narrative
Device evaluation completed on (b)(6) 2021.Visual analysis of the returned sample revealed that the medium height te 550cc tissue expander was found to have a tear at the union between shell and patch on the posterior view.Microscopic examination was performed and the cause of the tear could not be identified.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: MEDIUM HEIGHT TE 550CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11240658
• Report Number: 1645337-2021-00769
• Device Sequence Number: 3571291
• Product Code: LCJ
• UDI-Device Identifier: 00081317006558
• UDI-Public: 00081317006558
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2021

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: 01/07/2024
• Device Model Number: 3548214
• Device Catalogue Number: 3548214
• Device Lot Number: 9409240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/04/2021; 02/24/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/08/2021; 03/02/2021
• 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: 61 YR