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

Model Number	3504302M
Medical Device Problem Codes	Material Rupture (1546); Defective Device (2588)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/01/2020
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: n/a.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that two 250cc mentor tissue expanders were ¿impacted¿.No further information was provided.This report is for one of two devices.
Additional Manufacturer Narrative
Additional information: on may 4, 2020, the mentor failure analysis lab received the device for evaluation.On may 13, 2020, the product investigation was completed.Device investigation summary: during visual inspection of the device, a tear was observed on the posterior aspect measuring approximately 1.5 cm.Microscopic examination in the tear edges, revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.As part of our quality process, the manufacturing records of this 7643661 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
Additional information: on june 15, 2020, mentor became aware that the breast implants experienced bilateral rupture intraoperatively.On june 19, 2020, the updated product investigation was completed.Updated device investigation summary: during visual inspection of the device, a tear was observed on the posterior aspect measuring approximately 1.5 cm.Microscopic examination in the tear edges, revealed parallel striations that are consistent with markings made by a sharp instrument perforating silicone material.As part of our quality process, the manufacturing records of this (b)(6) 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).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10016307
• Report Number: 1645337-2020-05993
• Device Sequence Number: 3303673
• Product Code: LCJ
• UDI-Device Identifier: 00081317002383
• UDI-Public: 00081317002383
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2020

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: 10/28/2022
• Device Model Number: 3504302M
• Device Catalogue Number: 3504302M
• Device Lot Number: 7643661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 06/15/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/14/2020; 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1